Clinical trial NCT04897204: Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation
Official title: A Prospective Randomized Controlled Study of Additonal Left Atrial Appendage Electrical Isolation in Catheter Ablation Combined With Left Atrial Appendage Occlusion of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Left Atrial Appendage
Left Atrial Appendage Occlusion
Catheter Ablation
Keywords: Left Atrial Appendage Electrical Isolation
Atrial Fibrillation
Catheter Ablation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
First posted: 2021-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.

Detailed description: This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.

Eligibility criteria: Inclusion Criteria:

1. Age 18-85 years old;
2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
3. CHA2DS2-VASc score ≥ 2 points;
4. The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
5. Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.

Exclusion Criteria:

1. Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
2. There are plans for cardiac surgery within 90 days;
3. Stroke/transient ischemic attack occurred within 30 days;
4. Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
5. Heart failure NYHA heart function grade IV;
6. LVEF\<30%;
7. Combined with other serious diseases, the life expectancy is less than 2 years;
8. Within 6 months after cardiac revascularization or other cardiac surgery;
9. Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
10. Obviously abnormal liver and kidney function and coagulation function;

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: one year after operation
measure: Stroke/TIA
timeFrame: one year after operation
measure: Systemic embolism
timeFrame: one year after operation
measure: Hospitalization rate due to heart failure
timeFrame: one year after operation
measure: Cardiovascular death
timeFrame: one year after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913.
citation: Nyong J, Amit G, Adler AJ, Owolabi OO, Perel P, Prieto-Merino D, Lambiase P, Casas JP, Morillo CA. Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD012088. doi: 10.1002/14651858.CD012088.pub2.
citation: Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
citation: Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Gunes M, Gokoglan Y, Gianni C, Horton RP, Themistoclakis S, Gallinghouse GJ, Bailey S, Zagrodzky JD, Hongo RH, Beheiry S, Santangeli P, Casella M, Dello Russo A, Al-Ahmad A, Hranitzky P, Lakkireddy D, Tondo C, Natale A. Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial. J Am Coll Cardiol. 2016 Nov 1;68(18):1929-1940. doi: 10.1016/j.jacc.2016.07.770.
citation: Romero J, Michaud GF, Avendano R, Briceno DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, Di Biase L. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis. Europace. 2018 Aug 1;20(8):1268-1278. doi: 10.1093/europace/eux372.
citation: Fink T, Ouyang F, Heeger CH, Sciacca V, Reissmann B, Keelani A, Schutte C, Wohlmuth P, Maurer T, Rottner L, Eitel C, Eitel I, Rillig A, Metzner A, Kuck KH, Tilz RR, Vogler J. Management of thrombus formation after electrical isolation of the left atrial appendage in patients with atrial fibrillation. Europace. 2020 Sep 1;22(9):1358-1366. doi: 10.1093/europace/euaa174.
citation: Kim YG, Shim J, Oh SK, Lee KN, Choi JI, Kim YH. Electrical isolation of the left atrial appendage increases the risk of ischemic stroke and transient ischemic attack regardless of postisolation flow velocity. Heart Rhythm. 2018 Dec;15(12):1746-1753. doi: 10.1016/j.hrthm.2018.09.012.
citation: Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
citation: Belgaid DR, Khan Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Int J Cardiol. 2016 Sep 15;219:177-9. doi: 10.1016/j.ijcard.2016.06.041. Epub 2016 Jun 15.
citation: Mo BF, Sun J, Zhang PP, Li W, Chen M, Yuan JL, Yu Y, Wang QS, Li YG. Combined Therapy of Catheter Ablation and Left Atrial Appendage Closure for Patients with Atrial Fibrillation: A Case-Control Study. J Interv Cardiol. 2020 Jun 25;2020:8615410. doi: 10.1155/2020/8615410. eCollection 2020.
citation: Panikker S, Jarman JW, Virmani R, Kutys R, Haldar S, Lim E, Butcher C, Khan H, Mantziari L, Nicol E, Foran JP, Markides V, Wong T. Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study. Circ Arrhythm Electrophysiol. 2016 Jul;9(7):e003710. doi: 10.1161/CIRCEP.115.003710.
citation: Yorgun H, Canpolat U, Kocyigit D, Coteli C, Evranos B, Aytemir K. Left atrial appendage isolation in addition to pulmonary vein isolation in persistent atrial fibrillation: one-year clinical outcome after cryoballoon-based ablation. Europace. 2017 May 1;19(5):758-768. doi: 10.1093/europace/eux005.