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Safety of pulsed fi...
Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
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- Ekanem, Emmanuel (author)
- Icahn Sch Med Mt Sinai, NY 10029 USA; Valley Hlth Winchester Med Ctr, VA USA
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- Neuzil, Petr (author)
- Homolka Hosp, Czech Republic
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- Reichlin, Tobias (author)
- Bern Univ Hosp, Switzerland
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- Kautzner, Joseph (author)
- IKEM, Czech Republic
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- van der Voort, Pepijn (author)
- Catharina Ziekenhuis Eindhoven, Netherlands
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- Jais, Pierre (author)
- Univ Bordeaux, France
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- Chierchia, Gian-Battista (author)
- Univ Ziekenhuis Brussel, Belgium
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- Bulava, Alan (author)
- Univ South Bohemia Ceske Budejovice, Czech Republic
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- Blaauw, Yuri (author)
- Groningen Inst Archaeol, Netherlands
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- Skala, Tomas (author)
- Univ Hosp Olomouc, Czech Republic
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- Fiala, Martin (author)
- Masaryk Univ, Czech Republic
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- Duytschaever, Mattias (author)
- AZ Sint Jan Hosp Bruges, Belgium
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- Szeplaki, Gabor (author)
- Mater Private Hosp, Ireland; Royal Coll Surg Ireland RCSI, Ireland
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- Schmidt, Boris (author)
- Cardioangiol Ctr Bethanien, Germany
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- Massoullie, Gregoire (author)
- Clermont Ferrand Univ Hosp, France
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- Neven, Kars (author)
- Alfried Krupp Hosp, Germany; Witten Herdecke Univ, Germany
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- Thomas, Olivier (author)
- GHP Ambroise Pare Hartmann, France
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- Vijgen, Johan (author)
- Jessa Hosp, Belgium
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- Gandjbakhch, Estelle (author)
- Sorbonne Univ, France
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- Scherr, Daniel (author)
- Med Univ Graz, Austria
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- Johannessen, Arne (author)
- Copenhagen Univ Hosp, Denmark
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- Keane, David (author)
- Adaptemy, Ireland
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- Boveda, Serge (author)
- Clin Pasteur, France; Free Univ Brussels, Belgium
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- Maury, Philippe (author)
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- Garcia-Bolao, Ignacio (author)
- Univ Navarra, Spain; Inst Invest Sanitaria Navarra, Spain
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- Univ Hosp Ctr Split, Croatia
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- Sygehus Lillebaelt Rontgen Vejle, Denmark
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- Clin Millenaire, France
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- Ctr Cardiol Nord, France
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- Hop St Philibert, France
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- Liverpool Heart & Chest Hosp, England
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- Med Spectrum Twente, Netherlands
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- Defaye, Pascal (author)
- Grenoble Alpes Univ Hosp, France
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- Sticherling, Christian (author)
- Univ Hosp Basel, Switzerland
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- Sommer, Philipp (author)
- Ruhr Univ Bochum, Germany
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- Kucera, Pavel (author)
- Reg Hosp Liberec, Czech Republic
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- Osca, Joaquin (author)
- La Fe Univ & Polytech Hosp, Spain
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- Stockholm Ctr Org Res Score, Sweden
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- Roux, Antoine (author)
- Pole Sante Republ ELSAN, France
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- Uniklinikum RWTH Aachen, Germany
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- Osped Isola Tiberina Gemelli Isola, Italy
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- Adragao, Pedro (author)
- CHLO, Portugal
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- Solimene, Francesco (author)
- Clin Montevergine, Italy
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- Tondo, Claudio (author)
- Univ Milan, Italy
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- Russo, Antonio Dello (author)
- Dept Biomed Sci & Publ Hlth, Italy; Univ Hosp, Italy
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- Schreieck, Juergen (author)
- Univ Tubingen, Germany
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- Stadt Klinikum Karlsruhe, Germany
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- Universitatsklinikum Dusseldorf, Germany
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- Univ Hosp Munster, Germany
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- Univ Hosp Rouen, France
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- St Johannes Hosp Dortmund, Germany
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- Rosso, Raphael (author)
- Tel Aviv Sourasky Med Ctr, Israel
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- Metzner, Andreas (author)
- Univ Heart Vasc Ctr, Germany
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- Geller, Laszlo (author)
- Semmelweis Univ, Hungary
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- Baldinger, Samuel H. (author)
- Hirslanden Klin Beau Site, Switzerland
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- Ferrero, Angel (author)
- Hosp Clin Univ Valencia, Spain
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- Willems, Stephan (author)
- Asklepios Hosp St Georg, Germany
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- Goette, Andreas (author)
- St Vincenz Hosp, Germany; AFNET, Germany; Otto Von Guericke Univ, Germany
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- Mellor, Greg (author)
- Royal Papworth Hosp, England
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- Mathew, Shibu (author)
- Universitatsklinikum Essen, Germany
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- Szumowski, Lukasz (author)
- Natl Inst Cardiol, Poland
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- Tilz, Roland (author)
- Univ Hosp Schleswig Holstein, Germany; German Ctr Cardiovasc Res DZHK, Germany
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- Iacopino, Saverio (author)
- Maria Cecilia Hosp, Italy
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- Jacobsen, Peter Karl (author)
- Copenhagen Univ Hosp, Denmark
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- George, Andrikopoulos (author)
- Henry Dunant Hosp, Greece
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- Osmancik, Pavel (author)
- FNKV, Czech Republic
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- Spitzer, Stefan (author)
- Praxisklin Herz & Gefasse, Germany
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- Balasubramaniam, Richard (author)
- Royal Bournemouth Hosp, England
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- Parwani, Abdul Shokor (author)
- Campus Virchow Klinikum, Germany
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- Deneke, Thomas (author)
- Heart Ctr Bad Neustadt, Germany
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- Glowniak, Andrzej (author)
- Med Univ Lublin, Poland
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- Rossillo, Antonio (author)
- San Bortolo Hosp, Italy
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- Ordensklinikum Linz Elisabethinen, Austria
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- Duncker, David (author)
- Hannover Heart Rhythm Ctr, Germany
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- Reil, Peter (author)
- Klinikum Ingolstadt, Germany
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- Arentz, Thomas (author)
- Universitatsklinikum Freiburg, Germany
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- Steven, Daniel (author)
- Univ Cologne, Germany; Univ Cologne, Germany
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- Olalla, Juan Jose (author)
- Hosp Univ Marques Valdecilla, Spain
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- de Jong, Jonas S. S. G. (author)
- OLVG, Netherlands
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- Wakili, Reza (author)
- Univ Duisburg Essen, Germany; Goethe Univ Frankfurt Frankfurt, Germany
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- Abbey, Selim (author)
- CRENAU UMR, France
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- Christliches Klinikum Unna, Germany
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- Hosp Quironsalud, Spain
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- Hop Trousseau, France
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- Vivantes Klinikum Friedrichshain & Urban, Germany
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- Bergau, Leonard (author)
- Univ Med Ctr Gottingen, Germany
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- Lozano-Granero, Cristina (author)
- Univ Hosp Ramon y Cajal, Spain
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- Rivero, Maximo (author)
- Ziekenhuis Oost Limburg, Belgium
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- Breitenstein, Alexander (author)
- Kantonsspital Baden AG, Switzerland
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- Inkovaara, Jaakko (author)
- Tampere Univ, Finland
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- Fareh, Samir (author)
- Hop Croix Rousse, France
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- Latcu, Decebal Gabriel (author)
- Ctr Hospitalier Princesse Grace, Monaco
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- Linz, Dominik (author)
- Maastricht Univ, Netherlands; Univ Copenhagen, Denmark
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- Mueller, Patrick (author)
- Knappschaftskrankenhaus Recklinghausen, Germany
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- Ramos-Maqueda, Javier (author)
- Univ Hosp Clin Lozano Blesa, Spain; Aragon Hlth Res Inst, Spain
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- Beiert, Thomas (author)
- Univ Hosp Bonn, Germany
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- Themistoclakis, Sakis (author)
- Osped Angelo, Italy
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- Meininghaus, Dirk Grosse (author)
- Carl Thiem Klinikum Cottbus, Germany
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- Stix, Guenter (author)
- TIERARZLICHE HSCH WIEN, Austria
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- Tzeis, Stylianos (author)
- Mitera Hosp, Greece
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- Baran, Jakub (author)
- Med Univ Warsaw, Poland
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- Almroth, Henrik (author)
- Region Östergötland
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- Munoz, Daniel Rodriguez (author)
- Hosp Doce Octubre, Spain
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- de Sousa, Joao (author)
- St Maria Univ Hosp, Portugal
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- Efremidis, Michalis (author)
- Onassis Cardiac Surg Ctr, Greece
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- Balsam, Pawel (author)
- Med Univ Warsaw, Poland
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- Petru, Jan (author)
- Homolka Hosp, Czech Republic
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- Kueffer, Thomas (author)
- Bern Univ Hosp, Switzerland
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- Peichl, Petr (author)
- IKEM, Czech Republic
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- Dekker, Lukas (author)
- Catharina Ziekenhuis Eindhoven, Netherlands
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- Della Rocca, Domenico G. (author)
- Univ Ziekenhuis Brussel, Belgium
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- Moravec, Ondrej (author)
- Univ Hosp Olomouc, Czech Republic
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- Funasako, Moritoshi (author)
- Masaryk Univ, Czech Republic
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- Knecht, Sebastien (author)
- AZ Sint Jan Hosp Bruges, Belgium
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- Jauvert, Gael (author)
- Mater Private Hosp, Ireland
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- Chun, Julian (author)
- Cardioangiol Ctr Bethanien, Germany
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- Eschalier, Romain (author)
- Clermont Ferrand Univ Hosp, France
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- Fueting, Anna (author)
- Alfried Krupp Hosp, Germany; Witten Herdecke Univ, Germany
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- Zhao, Alexandre (author)
- GHP Ambroise Pare Hartmann, France
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- Koopman, Pieter (author)
- Jessa Hosp, Belgium
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- Laredo, Mikael (author)
- Sorbonne Univ, France
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- Manninger, Martin (author)
- Med Univ Graz, Austria
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- Hansen, Jim (author)
- Copenhagen Univ Hosp, Denmark
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- O'Hare, Daniel (author)
- Adaptemy, Ireland
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- Rollin, Anne (author)
- Univ Hosp Rangueil, France
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- Jurisic, Zrinka (author)
- Univ Hosp Ctr Split, Croatia
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- Fink, Thomas (author)
- Ruhr Univ Bochum, Germany
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- Chaumont, Corentin (author)
- Univ Hosp Rouen, France
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- Rillig, Andreas (author)
- Univ Heart Vasc Ctr, Germany
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- Gunawerdene, Melanie (author)
- Asklepios Hosp St Georg, Germany
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- Martin, Claire (author)
- Royal Papworth Hosp, England
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- Kirstein, Bettina (author)
- Univ Hosp Schleswig Holstein, Germany; German Ctr Cardiovasc Res DZHK, Germany
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- Nentwich, Karin (author)
- Heart Ctr Bad Neustadt, Germany
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- Lehrmann, Heiko (author)
- Universitatsklinikum Freiburg, Germany
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- Sultan, Arian (author)
- Univ Cologne, Germany; Univ Cologne, Germany
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- Bohnen, Jan (author)
- Univ Duisburg Essen, Germany; Goethe Univ Frankfurt Frankfurt, Germany
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- Turagam, Mohit K. (author)
- Icahn Sch Med Mt Sinai, NY 10029 USA
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- Reddy, Vivek Y. (author)
- Icahn Sch Med Mt Sinai, NY 10029 USA; Homolka Hosp, Czech Republic
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(creator_code:org_t)
- 2024
- 2024
- English.
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In: Nature Medicine. - : NATURE PORTFOLIO. - 1078-8956 .- 1546-170X.
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for similar to 1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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Ekanem, Emmanuel
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Neuzil, Petr
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Reichlin, Tobias
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Kautzner, Joseph
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van der Voort, P ...
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Jais, Pierre
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Chierchia, Gian- ...
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Bulava, Alan
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Blaauw, Yuri
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Skala, Tomas
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Fiala, Martin
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Duytschaever, Ma ...
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Szeplaki, Gabor
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Schmidt, Boris
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Massoullie, Greg ...
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Neven, Kars
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Thomas, Olivier
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Vijgen, Johan
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Gandjbakhch, Est ...
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Scherr, Daniel
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Johannessen, Arn ...
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Keane, David
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Boveda, Serge
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Maury, Philippe
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Garcia-Bolao, Ig ...
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Anic, Ante
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Hansen, Peter St ...
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Raczka, Franck
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Lepillier, Antoi ...
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Guyomar, Yves
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Gupta, Dhiraj
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Van Opstal, Jurr ...
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Defaye, Pascal
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Sticherling, Chr ...
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Sommer, Philipp
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Kucera, Pavel
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Osca, Joaquin
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Tabrizi, Faribor ...
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Roux, Antoine
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Gramlich, Michae ...
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Bianchi, Stefano
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Adragao, Pedro
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Solimene, France ...
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Tondo, Claudio
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Russo, Antonio D ...
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Schreieck, Juerg ...
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Luik, Armin
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Rana, Obaida
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Frommeyer, Gerri ...
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Anselme, Frederi ...
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Kreis, Ingo
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Rosso, Raphael
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Metzner, Andreas
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Geller, Laszlo
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Baldinger, Samue ...
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Ferrero, Angel
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Willems, Stephan
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Goette, Andreas
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Mellor, Greg
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Mathew, Shibu
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Szumowski, Lukas ...
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Tilz, Roland
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Iacopino, Saveri ...
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Jacobsen, Peter ...
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George, Andrikop ...
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Osmancik, Pavel
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Spitzer, Stefan
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Balasubramaniam, ...
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Parwani, Abdul S ...
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Deneke, Thomas
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Glowniak, Andrze ...
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Rossillo, Antoni ...
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Puererfellner, H ...
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Duncker, David
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Reil, Peter
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Arentz, Thomas
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Steven, Daniel
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Olalla, Juan Jos ...
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de Jong, Jonas S ...
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Wakili, Reza
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Abbey, Selim
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Timo, Gottschlin ...
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Asso, Antonio
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Wong, Tom
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Pierre, Bertrand
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Ewertsen, Niels ...
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Bergau, Leonard
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Lozano-Granero, ...
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Rivero, Maximo
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Breitenstein, Al ...
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Inkovaara, Jaakk ...
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Fareh, Samir
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Latcu, Decebal G ...
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Linz, Dominik
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Mueller, Patrick
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Ramos-Maqueda, J ...
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Beiert, Thomas
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Themistoclakis, ...
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Meininghaus, Dir ...
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Stix, Guenter
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Tzeis, Stylianos
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Baran, Jakub
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Almroth, Henrik
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Munoz, Daniel Ro ...
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de Sousa, Joao
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Efremidis, Micha ...
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Balsam, Pawel
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Petru, Jan
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Kueffer, Thomas
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Peichl, Petr
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Dekker, Lukas
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Della Rocca, Dom ...
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Moravec, Ondrej
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Funasako, Morito ...
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Knecht, Sebastie ...
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Jauvert, Gael
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Chun, Julian
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Eschalier, Romai ...
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Fueting, Anna
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Zhao, Alexandre
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Koopman, Pieter
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Laredo, Mikael
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Manninger, Marti ...
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Hansen, Jim
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O'Hare, Daniel
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Rollin, Anne
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Jurisic, Zrinka
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Fink, Thomas
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Chaumont, Corent ...
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Rillig, Andreas
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Gunawerdene, Mel ...
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Martin, Claire
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Kirstein, Bettin ...
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Nentwich, Karin
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Lehrmann, Heiko
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Sultan, Arian
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Bohnen, Jan
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Turagam, Mohit K ...
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Reddy, Vivek Y.
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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Nature Medicine
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Linköping University