Jean Sylvain Hermida1, Jian Chen2, Christian Meyer3, Saverio Iacopino4, Giuseppe Arena5, Nikola Pavlovic6, Vedran Velagic7, Stewart Healey8, Douglas L Packer9, Heinz-Friedrich Pitschner10, Carlo de Asmundis11, Malte Kuniss10, Gian Battista Chierchia11. 1. Centre Hospitalier Universitaire d'Amiens-Picardie, Amiens, FR. Electronic address: hermida.jean-sylvain@chu-amiens.fr. 2. Haukeland University Hospital, Bergen, NO. 3. University Heart Center, Hamburg, DE. 4. Villa Maria Cecilia, Cotignola, IT. 5. Ospedale Apuane, Massa Carrara, IT. 6. Sestre Milosrdnice University Hospital Centre, Zagreb, HR. 7. University Hospital Centre Zagreb, Zagreb, HR. 8. Monash Health, Clayton, AUS. 9. Mayo Clinic Hospital - St. Mary's Campus, Rochester, MN, USA. 10. Kerckhoff Heart Center, Bad Nauheim, DE. 11. Universitair Ziekenhuis Brussel, Brussel, BE.
Abstract
BACKGROUND:Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF. OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups. METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers. CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.
RCT Entities:
BACKGROUND: Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF. OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups. METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers. CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.
Authors: Joerelle Mojica; Felicia Lipartiti; Maysam Al Housari; Gezim Bala; Shuichiro Kazawa; Vincenzo Miraglia; Cinzia Monaco; Ingrid Overeinder; Antanas Strazdas; Robbert Ramak; Gaetano Paparella; Juan Sieira; Lucio Capulzini; Antonio Sorgente; Erwin Stroker; Pedro Brugada; Carlo De Asmundis; Gian-Battista Chierchia Journal: J Atr Fibrillation Date: 2021-06-30
Authors: Malte Kuniss; Nikola Pavlovic; Vedran Velagic; Jean Sylvain Hermida; Stewart Healey; Giuseppe Arena; Nicolas Badenco; Christian Meyer; Jian Chen; Saverio Iacopino; Frédéric Anselme; Douglas L Packer; Heinz-Friedrich Pitschner; Carlo de Asmundis; Stephan Willems; Fabio Di Piazza; Daniel Becker; Gian-Battista Chierchia Journal: Europace Date: 2021-07-18 Impact factor: 5.214