Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation

Summary

The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.

Timeline

Start

2024-02-01

Primary completion

2030-12-31

Completion

2030-12-31

Publications

• Background Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.
• Background Waks JW, Passman RS, Matos J, Reynolds M, Thosani A, Mela T, Pederson D, Glotzer TV, Zimetbaum P. Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study. Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.
• Background Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.
• Background Karasoy D, Gislason GH, Hansen J, Johannessen A, Kober L, Hvidtfeldt M, Ozcan C, Torp-Pedersen C, Hansen ML. Oral anticoagulation therapy after radiofrequency ablation of atrial fibrillation and the risk of thromboembolism and serious bleeding: long-term follow-up in nationwide cohort of Denmark. Eur Heart J. 2015 Feb 1;36(5):307-14a. doi: 10.1093/eurheartj/ehu421. Epub 2014 Nov 3.
• Background Themistoclakis S, Corrado A, Marchlinski FE, Jais P, Zado E, Rossillo A, Di Biase L, Schweikert RA, Saliba WI, Horton R, Mohanty P, Patel D, Burkhardt DJ, Wazni OM, Bonso A, Callans DJ, Haissaguerre M, Raviele A, Natale A. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.

Drugs

Indications