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2. Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results

Author

Hascoet, Sebastien, Baruteau, Alban-Elouen, Jalal, Zakaria, Demkow, Marcin, de Winter, Robbert, Gaio, Gianpiero, Clerc, Jean-Michel, Sabiniewicz, Robert, Eberli, Franz, Santoro, Giuseppe, Dauphin, Claire, Schubert, Stephan, Smolka, Grzegorz, Lutz, Matthias, Moreno, Raul, Pan, Manuel, Gutierrez-Larraya, Federico, Godart, Francois, Carminati, Mario, Ovaert, Caroline, Batteux, Clement, Guerin, Patrice, Thambo, Jean-Benoit, and Ewert, Peter

Published
2023
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3. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study

Author

Hauguel-Moreau, Marie, Guedeney, Paul, Dauphin, Claire, Auffret, Vincent, Marijon, Eloi, Aldebert, Philippe, Clerc, Jean-Michel, Beygui, Farzin, Elbaz, Meyer, Khalil, Wissam Abi, Da Costa, Antoine, Macia, Jean-Christophe, Elhadad, Simon, Cayla, Guillaume, Brugier, Delphine, Silvain, Johanne, Hammoudi, Nadjib, Duthoit, Guillaume, Vicaut, Eric, and Montalescot, Gilles

Abstract

Graphical AbstractDesign of the AFLOAT trial; AA: atrial arrhythmia; ICM = insertable cardiac monitor; od = once a day; PFO = patent foramen ovale; SR = sustained-release.

Published
2024
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4. Prevalence, management and outcomes of percutaneous coronary intervention for coronary in-stent restenosis: Insights from the France PCI Registry

Author

Duband, Benjamin, primary, Souteyrand, Géraud, additional, Clerc, Jean Michel, additional, Chassaing, Stephan, additional, Fichaux, Olivier, additional, Marcollet, Pierre, additional, Deballon, Ronan, additional, Roussel, Laurent, additional, Pereira, Bruno, additional, Collet, Jean-Philippe, additional, Commeau, Philippe, additional, Cayla, Guillaume, additional, Koning, Rene, additional, Motreff, Pascal, additional, Benamer, Hakim, additional, and Rangé, Gregoire, additional

Published
2023
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6. Management and outcome of patients with established coronary artery disease: the Euro Heart Survey on coronary revascularization

Author

Lenzen, M. J., Boersma, E., Bertrand, M. E., Maier, W., Moris, C., Piscione, F., Sechtem, U., Stahle, E., Widimsky, P., De Jaegere, P., Scholte Op Reimer, W. J. M., Mercado, N., Wijns, W., Meier, B., Sergeant, P., Vos, J., Unger, F., Manini, Malika, Bramley, Claire, Laforest, Valérie, Taylor, Charles, Del Gaiso, Susan, Huber, Kurt, De Backer, Guy, Sirakova, Vera, Cerbak, Roman, Thayssen, Per, Lehto, Seppo, Blanc, Jean-Jacques, Delahaye, François, Kobulia, Bondo, Zeymer, Uwe, Cokkinos, Dennis, Karlocai, Kristof, Graham, Ian, Shelley, Emer, Behar, Shlomo, Maggioni, Aldo, Grabauskiene, Virginija, Deckers, Jaap, Asmussen, Inger, Stepinska, Janina, Gonçalves, Lino, Mareev, Vyacheslav, Riecansky, Igor, Kenda, Miran F., Alonso, Angeles, Lopez-Sendon, José Luis, Rosengren, Annika, Buser, Peter, Okay, Tugrul, Sychov, Oleg, Fox, Kevin, Wood, David, Boersma, Eric, Crijns, Harry, Fox, Kim, McGregor, Keith, Mulder, Barbara, Priori, Sylvia, Rydén, Lars, Tavazzi, Luigi, Vahanian, Alec, Vardas, Panos, Wijns, William, Sarkisyan, Karine, Glogar, H. D., Derntl, Michael, Frick, Matthias, Pachinger, O., Zwick, Ralf, Vrints, Christiaan, Van Hertbruggen, Els, Vercammen, Marc, Sysmans, Tineke, Schroeder, E., Domange, Juliette, De Pril, Hilde, De Vriese, Johan, Van Hecke, Tonny, Legrand, V., Gillon, Marie-France, Richardy, Michel, Doneux, P., Petrov, Ivo, Jorgova, J., Starcevic, Boris, Eeckhout, Eric, Berger, Alexandre, Prudent, Veronique, Camenzind, E., Masson, Nicolas, Zambartas, Costas, Kleanthous, Helen, Widimsky, Petr, Stellova, Blanka, Aschermann, Michael, Simek, Stanislav, Kautzner, J., Karmazin, Vladimir, Svab, P., Indrak, Jan, Branny, M., Hladilova, Kveta, Kala, P., Thayssen, P., Cappelen, Helle, Jensen, Lisette Okkels, Gitt, A., Gehrke, Konstanze, Erbel, R., Gutersohn, Achim, Eggebrecht, Holger, Al Khani, Murad, Sechtem, Udo, Rosenberger, Antje, Vogelsberg, Holger, Klepzig, H., Schmidt, Arnold, Silber, Sigmund, Mau, Birgit, Leuner, Christian, Czyborra, Karen, Reuschling, Christina, Muno, Eva, Kleber, F., Rux, Sascha, Zeymer, U., Saad, Aly, Ibrahim, B. S. S., Elabady, Maged, Castro Beiras, A., Fernandez, Jorge Salgado, Navarro Del Arno, Felipe, Iniguez Romo, A., Cruz Fernandez, J. M., Mayoreal, Alejandro Recio, Rebanal, Franciso Javier Rivero, De La Borbolla, Mariano Garcia, Chaparro, Marinela, Brotons, C., Permanyer Miralda, C., Vilai Perez, Srta Irma, Moris, Cesar, Fernandez Aviles, F., De La Fuente Galan, Luis, Vinuela, Paula Tejedor, Malpartida De Torres, F., Mora, Javier, Rodriguez, Ignacio Santos, Bustamante, Itziar Piedra, Sanchez Fernandez, Pedro L., Diago Torrent, J. L., Diez Gil, Jose L., Perpinan, Javier, Palacios Motilla, V., Soledad Alcasena Juango, M., Berjon-Reyero, Jesus, Melgares Moreno, R., Guerrero, Juan Carlos Fernandez, Lehto, S., Savolainen, Kirsti, Nieminen, M. S., Syvanne, Mikko, Cohen-Solal, A., Oboa, Antoine-Sylvain, Bassand, J. P., Espinosa, Denis Pales, Jouet, Veronique, Montalescot, G., Gallois, Vanessa, Daubert, J. C., Clerc, Jean Michel, Machecourt, Jacques, Cottin, Y., Walker, D., Holland, Fhiona, Wood, D., Prosser, Jenni, Muir, Lis, Barber, Kate, Cleland, J. G. F., Cook, Jocelyn, Chapichadze, Zaza, Christos, Ioannis Skoularigisn Athanasiou, Tsiavou, Nastasia, Chrysohoou, Christina, Manginas, Athanassios, Terrovitis, John, Kanakakis, John, Vavuranakis, Manolis, Drakos, Stavros, Farmakis, Thomas, Samara, C., Papakosta, Christina, Bourantas, Christos, Michalis, L. K., Christos, Mpourantas, Foussas, Stefanos, Adamopoulou, Evdokia, Vardas, P. E., Marketou, Mary, Alotti, N., Basa, Anna Maria, Vigh, Andras, Preda, Istvan, Csoti, Eva, Keltai, M., Kerkovits, G., Hendler, Alberto, Blatt, Alex, Beyar, R., Shefer, Arie, Halon, David, Bentzvi, Margalait, Avramovitch, Naomi, Bakst, Avinoam, Cafri, Carlos, Grosbard, Aviva, Margolis, Bella, Suleiman, Khalid, Banai, Shmuel, Meerkin, David, Mosseri, Morris, Guita, Pnina, Jabara, Rifat, Jafari, Jamal, Ben Shitrit, Debi, Ghasan, null, Salameh, null, Brezins, Marc, Van Den Akker-Berman, Lily, Guetta, Victor, Rozenman, Yoseph, Biagini, A., Berti, Sergio, Ferrero, Massimo, Colombo, A., Roccaforte, R., Milici, Caterina, Scarpino, L., Salvi, A., Desideri, Alessandro, Sabbadin, Daniela, Galassi, Alfredo, Giuffrida, Giuseppe, Rognoni, Andrea, Vassanelli, Corrado, Paffoni, Paola, Cioppa, Angelo, Rubino, Paolo, De Carlo, Marco, Petronio, Anna Sonia, Naccarella, F., Saia, Francesco, Marzocchi, Antonio, Maranga, Stefano Sdringola, Presbitero, P., Valsecchi, Fazya, Piscione, Federico, Esposito, Giovanni, Santini, Napoli M., Tubaro, Marco, Erglis, A., Narbute, Inga, Kavoliuniene, Ausra, Zaliunas, R., Navickas, Ramunas, Grabauskiene, V., Luckute, Davia, Subkovas, Eduardas, Wagner, Daniel, Vermeer, F., Lousberg, Aimee, Fransen, Heidi, Breeman, Arno, Tebbe, Henriette, De Boer, M. J., Van Der Wal, Metske, Deckers, J., Vos, Jeroen, Leenders, C. M., Veerhoek, M. J., Jansen, Chris, Bijl, M., Koppelaar, Colinda, Van Den Linden, null, Brons, R., Widdershofen, J. W. M. G., Broers, Herman, Kontny, F., Jonzon, Marianne, Wodniecki, Jan, Tomasik, Andrzej, Trusz-Gluza, M., Nowak, Seweryn, Ruzyllo, Witold, Deptuch, Tomasz, Marques, Jorge, Matias, F., Madeira, H., Oliveira, Joaquim, Sargento, Luis, Ionac, Adina, Dragulescu, Iosif Stefan, Mut-Vitcu, Bogdan, Maximov, Daniela, Dorobantu, M., Apetrei, E., Niculescu, Rodica, Petrescu, Virgil, Bucsa, Adrian, Deleanu, Dan, Benedek, I. S., Hintea, Theodora, Aronov, D., Tikhomirova, Elena, Kranjec, I., Prokselj, Katja, Kanic, Vojko, Sepetoglu, Ahmet, Aytekin, S., Aytekin, V., Catakoglu, Alp Burak, Parlar, Hayri, Tufekcioglu, Suavi, Ozyedek, Zeki, Baltali, Mehmet, Kiziltan, null, Vukovic, Milan, Neskovic, A. N., Lenzen, M. J, Boersma, E, Bertrand, Me, Maier, W, Moris, C, Esposito, Giovanni, Piscione, Federico, Sechtem, U, Stahle, E, Widimsky, P, de Jaegere, P, Scholte op Reimer, W. J. M, Mercado, N, Wijns, W., University of Zurich, Wijns, W, Lenzen, M. J., Boersma, E., Bertrand, M. E., Maier, W., Moris, C., Piscione, F., Sechtem, U., Stahle, E., Widimsky, P., De Jaegere, P., Scholte Op Reimer, W. J. M., Mercado, N., Meier, B., Sergeant, P., Vos, J., Unger, F., Manini, Malika, Bramley, Claire, Laforest, Valérie, Taylor, Charle, Del Gaiso, Susan, Huber, Kurt, De Backer, Guy, Sirakova, Vera, Cerbak, Roman, Thayssen, Per, Lehto, Seppo, Blanc, Jean-Jacque, Delahaye, Françoi, Kobulia, Bondo, Zeymer, Uwe, Cokkinos, Denni, Karlocai, Kristof, Graham, Ian, Shelley, Emer, Behar, Shlomo, Maggioni, Aldo, Grabauskiene, Virginija, Deckers, Jaap, Asmussen, Inger, Stepinska, Janina, Gonçalves, Lino, Mareev, Vyacheslav, Riecansky, Igor, Kenda, Miran F., Alonso, Angele, Lopez-Sendon, José Lui, Rosengren, Annika, Buser, Peter, Okay, Tugrul, Sychov, Oleg, Fox, Kevin, Wood, David, Boersma, Eric, Crijns, Harry, Fox, Kim, Mcgregor, Keith, Mulder, Barbara, Priori, Sylvia, Rydén, Lar, Tavazzi, Luigi, Vahanian, Alec, Vardas, Pano, Wijns, William, Sarkisyan, Karine, Glogar, H. D., Derntl, Michael, Frick, Matthia, Pachinger, O., Zwick, Ralf, Vrints, Christiaan, Van Hertbruggen, El, Vercammen, Marc, Sysmans, Tineke, Schroeder, E., Domange, Juliette, De Pril, Hilde, De Vriese, Johan, Van Hecke, Tonny, Legrand, V., Gillon, Marie-France, Richardy, Michel, Doneux, P., Petrov, Ivo, Jorgova, J., Starcevic, Bori, Eeckhout, Eric, Berger, Alexandre, Prudent, Veronique, Camenzind, E., Masson, Nicola, Zambartas, Costa, Kleanthous, Helen, Widimsky, Petr, Stellova, Blanka, Aschermann, Michael, Simek, Stanislav, Kautzner, J., Karmazin, Vladimir, Svab, P., Indrak, Jan, Branny, M., Hladilova, Kveta, Kala, P., Thayssen, P., Cappelen, Helle, Jensen, Lisette Okkel, Gitt, A., Gehrke, Konstanze, Erbel, R., Gutersohn, Achim, Eggebrecht, Holger, Al Khani, Murad, Sechtem, Udo, Rosenberger, Antje, Vogelsberg, Holger, Klepzig, H., Schmidt, Arnold, Silber, Sigmund, Mau, Birgit, Leuner, Christian, Czyborra, Karen, Reuschling, Christina, Muno, Eva, Kleber, F., Rux, Sascha, Zeymer, U., Saad, Aly, Ibrahim, B. S. S., Elabady, Maged, Castro Beiras, A., Fernandez, Jorge Salgado, Navarro Del Arno, Felipe, Iniguez Romo, A., Cruz Fernandez, J. M., Mayoreal, Alejandro Recio, Rebanal, Franciso Javier Rivero, De La Borbolla, Mariano Garcia, Chaparro, Marinela, Brotons, C., Permanyer Miralda, C., Vilai Perez, Srta Irma, Moris, Cesar, Fernandez Aviles, F., De La Fuente Galan, Lui, Vinuela, Paula Tejedor, Malpartida De Torres, F., Mora, Javier, Rodriguez, Ignacio Santo, Bustamante, Itziar Piedra, Sanchez Fernandez, Pedro L., Diago Torrent, J. L., Diez Gil, Jose L., Perpinan, Javier, Palacios Motilla, V., Soledad Alcasena Juango, M., Berjon-Reyero, Jesu, Melgares Moreno, R., Guerrero, Juan Carlos Fernandez, Lehto, S., Savolainen, Kirsti, Nieminen, M. S., Syvanne, Mikko, Cohen-Solal, A., Oboa, Antoine-Sylvain, Bassand, J. P., Espinosa, Denis Pale, Jouet, Veronique, Montalescot, G., Gallois, Vanessa, Daubert, J. C., Clerc, Jean Michel, Machecourt, Jacque, Cottin, Y., Walker, D., Holland, Fhiona, Wood, D., Prosser, Jenni, Muir, Li, Barber, Kate, Cleland, J. G. F., Cook, Jocelyn, Chapichadze, Zaza, Christos, Ioannis Skoularigisn Athanasiou, Tsiavou, Nastasia, Chrysohoou, Christina, Manginas, Athanassio, Terrovitis, John, Kanakakis, John, Vavuranakis, Manoli, Drakos, Stavro, Farmakis, Thoma, Samara, C., Papakosta, Christina, Bourantas, Christo, Michalis, L. K., Christos, Mpouranta, Foussas, Stefano, Adamopoulou, Evdokia, Vardas, P. E., Marketou, Mary, Alotti, N., Basa, Anna Maria, Vigh, Andra, Preda, Istvan, Csoti, Eva, Keltai, M., Kerkovits, G., Hendler, Alberto, Blatt, Alex, Beyar, R., Shefer, Arie, Halon, David, Bentzvi, Margalait, Avramovitch, Naomi, Bakst, Avinoam, Cafri, Carlo, Grosbard, Aviva, Margolis, Bella, Suleiman, Khalid, Banai, Shmuel, Meerkin, David, Mosseri, Morri, Guita, Pnina, Jabara, Rifat, Jafari, Jamal, Ben Shitrit, Debi, Ghasan, Null, Salameh, Null, Brezins, Marc, Van Den Akker-Berman, Lily, Guetta, Victor, Rozenman, Yoseph, Biagini, A., Berti, Sergio, Ferrero, Massimo, Colombo, A., Roccaforte, R., Milici, Caterina, Scarpino, L., Salvi, A., Desideri, Alessandro, Sabbadin, Daniela, Galassi, Alfredo, Giuffrida, Giuseppe, Rognoni, Andrea, Vassanelli, Corrado, Paffoni, Paola, Cioppa, Angelo, Rubino, Paolo, De Carlo, Marco, Petronio, Anna Sonia, Naccarella, F., Saia, Francesco, Marzocchi, Antonio, Maranga, Stefano Sdringola, Presbitero, P., Valsecchi, Fazya, Santini, Napoli M., Tubaro, Marco, Erglis, A., Narbute, Inga, Kavoliuniene, Ausra, Zaliunas, R., Navickas, Ramuna, Grabauskiene, V., Luckute, Davia, Subkovas, Eduarda, Wagner, Daniel, Vermeer, F., Lousberg, Aimee, Fransen, Heidi, Breeman, Arno, Tebbe, Henriette, De Boer, M. J., Van Der Wal, Metske, Deckers, J., Vos, Jeroen, Leenders, C. M., Veerhoek, M. J., Jansen, Chri, Bijl, M., Koppelaar, Colinda, Van Den Linden, Null, Brons, R., Widdershofen, J. W. M. G., Broers, Herman, Kontny, F., Jonzon, Marianne, Wodniecki, Jan, Tomasik, Andrzej, Trusz-Gluza, M., Nowak, Seweryn, Ruzyllo, Witold, Deptuch, Tomasz, Marques, Jorge, Matias, F., Madeira, H., Oliveira, Joaquim, Sargento, Lui, Ionac, Adina, Dragulescu, Iosif Stefan, Mut-Vitcu, Bogdan, Maximov, Daniela, Dorobantu, M., Apetrei, E., Niculescu, Rodica, Petrescu, Virgil, Bucsa, Adrian, Deleanu, Dan, Benedek, I. S., Hintea, Theodora, Aronov, D., Tikhomirova, Elena, Kranjec, I., Prokselj, Katja, Kanic, Vojko, Sepetoglu, Ahmet, Aytekin, S., Aytekin, V., Catakoglu, Alp Burak, Parlar, Hayri, Tufekcioglu, Suavi, Ozyedek, Zeki, Baltali, Mehmet, Kiziltan, Null, Vukovic, Milan, Neskovic, A. N., Cardiology, Lenzen, Mj, and Scholte op Reimer, Wj

Subjects
Practice survey, Male, Coronary Stenosi, Coronary angiography, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, Angina, Coronary artery disease, Myocardial Revascularization, Stent, Myocardial infarction, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, CABG, PCI, Professional Practice, Health Survey, Middle Aged, Europe, Treatment Outcome, Epidemiologic Method, Practice Guidelines as Topic, Cardiology, Stents, Female, Guideline Adherence, Cardiology and Cardiovascular Medicine, Human, medicine.medical_specialty, outcome, Euro Heart Survey, 610 Medicine & health, Platelet Glycoprotein GPIIb-IIIa Complex, 142-005 142-005, 2705 Cardiology and Cardiovascular Medicine, Angioplasty, Internal medicine, medicine, Humans, Angina, Unstable, cardiovascular diseases, Interventional cardiology, Unstable angina, business.industry, Coronary Artery Bypa, Coronary Stenosis, Percutaneous coronary intervention, Length of Stay, medicine.disease, Health Surveys, Conventional PCI, 570 Life sciences, biology, Epidemiologic Methods, business
Abstract

AIMS: The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive diagnosis and treatment of patients with established coronary artery disease (CAD). METHODS AND RESULTS: Between November 2001 and March 2002, 7769 consecutive patients undergoing invasive evaluation at 130 hospitals (31 countries) were screened for the presence of one or more coronary stenosis >50% in diameter. Patient demographics and comorbidity, clinical presentation, invasive parameters, treatment options, and procedural techniques were prospectively entered in an electronic database (550 variables+29 per diseased coronary segment). Major adverse cardiac events (MACE) were evaluated at 30 days and 1 year. Out of 5619 patients with angiographically proven coronary stenosis (72% of screened population), 53% presented with stable angina while ST elevation myocardial infarction (STEMI) was the indication for coronary angiography in 16% and non-ST segment elevation myocardial infarction or unstable angina in 30%. Only medical therapy was continued in 21%, whereas mechanical revascularization was performed in the remainder [percutaneous coronary intervention (PCI) in 58% and coronary artery bypass grafting (CABG) in 21%]. Patients referred for PCI were younger, were more active, had a lower risk profile, and had less comorbid conditions. CABG was performed mostly in patients with left main lesions (21%), two- (25%), or three-vessel disease (67%) with 4.1 diseased segments, on average. Single-vessel PCI was performed in 82% of patients with either single- (45%), two- (33%), or three-vessel disease (21%). Stents were used in 75% of attempted lesions, with a large variation between sites. Direct PCI for STEMI was performed in 410 cases, representing 7% of the entire workload in the participating catheterization laboratories. Time delay was within 90 min in 76% of direct PCI cases. In keeping with the recommendations of practice guidelines, the survey identified under-use of adjunctive medication (GP IIb/IIIa receptor blockers, statins, and angiotensin-converting enzyme-inhibitors). Mortality rates at 30 days and 1 year were low in all subgroups. MACE primarily consisted of repeat PCI (12%). CONCLUSION: The current Euro Heart Survey on coronary revascularization was performed in the era of bare metal stenting and provides a global European picture of the invasive approach to patients with CAD. These data will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of interventional cardiology and bypass surgery.

Published
2005

9. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences.

Author

Guétin, Stéphane, Brun, Luc, Deniaud, Maelle, Clerc, Jean-Michel, Thayer, Julian F., and Koenig, Julian

Subjects
*MUSIC therapy, *MOBILE apps, *PAIN management, *ANXIETY treatment, *SEXUAL dimorphism
Abstract

Background • Music Care is a smartphone-based application providing a musical intervention for the management of pain and anxiety in a clinical setting. Coronarography is a medical procedure frequently associated with examination anxiety. Objectives • The study intended to perform an initial evaluation of the application for use with patients undergoing a coronarography. Design • The research team performed an uncontrolled, observational study. Setting • The study took place at Nouméa General Hospital in Nouméa, New Caledonia, France. Participants • Participants were 35 patients, 17 women and 18 men, who were undergoing a coronarography between November 2010 and April 2011 at the Nouméa General Hospital. Intervention • Participants listened to a standardized musical sequence of adjustable length by choosing a preferred style of music (eg, classic rock or folk music) from a variety of choices that the research team had chosen to include in the application. Outcome Measures • Before and after listening to the music, all participants were asked to rate their anxiety and pain on an 11-item, visual analogue scale and to complete a questionnaire on their satisfaction with use of the application. Results • The paired sample t test revealed a significant reduction in participants’ anxiety (t33 = 4.12, P < .0001) after they had listened to the music. No significant reduction in self-reported pain occurred; however, only a few participants reported pain associated with the procedure. No significant sex differences existed. Women and men both showed reduced anxiety after listening to music as well as reported a high level of satisfaction in using the Music Care application. Conclusions • The smartphone-based Music Care application is an easy-to-use tool to reduce anxiety in patients undergoing coronarography. Future large-scale, controlled trials are necessary to compare its effectiveness with other interventions. Both women and men can benefit from the use of the application. [ABSTRACT FROM AUTHOR]

Published
2016

10. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study.

Author

Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Marijon E, Aldebert P, Clerc JM, Beygui F, Elbaz M, Khalil WA, Da Costa A, Macia JC, Elhadad S, Cayla G, Brugier D, Silvain J, Hammoudi N, Duthoit G, Vicaut E, and Montalescot G

Subjects
Adult, Female, Humans, Male, Middle Aged, Heart Rate drug effects, Prospective Studies, Time Factors, Treatment Outcome, Anti-Arrhythmia Agents therapeutic use, Anti-Arrhythmia Agents adverse effects, Anti-Arrhythmia Agents administration & dosage, Atrial Fibrillation diagnosis, Atrial Fibrillation prevention & control, Flecainide adverse effects, Flecainide administration & dosage, Flecainide therapeutic use, Foramen Ovale, Patent complications, Foramen Ovale, Patent therapy
Abstract

Introduction: Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown., Methods/design: The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150 mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150 mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30 s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study., Conclusion: AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure., Clinical Trial Registration: NCT05213104 (clinicaltrials.gov)., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2024
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