This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Dr Tomáš Ostřížek
Brno, Czechia
Czech Budejovice Hospital, Inc.
České Budějovice, Czechia
Cardiovascular Center Bad Neustadt
Bad Neustadt an der Saale, Germany
Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
Bad Rothenfelde, Germany
Heart Center Leipzig
Leipzig, Germany
Klinikum Ludwigsburg
Ludwigsburg, Germany
Peter Osypka Heart Center Munich
Munich, Germany
Kliniken Sindelfingen
Sindelfingen, Germany
Sana Heart Center Stuttgart
Stuttgart, Germany
St. Antonius Hospital
Nieuwegein, Netherlands
...and 2 more locations
Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).
Time frame: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs.
Time frame: Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
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