Left Atrial Appendage Closure in Combination With Catheter Ablation

NCT03788941 | Unknown

• 1 other identifier: XH-18-015
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• stroke/TIA/systemic embolism

  The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.

  long-term after the procedure.

• Major bleeding

  The incidence of major bleeding in the participants will be reported.

  long-term after the procedure.

• Death

  all-cause death

  long-term after the procedure.

Secondary Outcomes (3)

• maintenance of sinus rhythm

  after the procedure outside the 3-month blanking period

• procedure-related complications

  after the procedure.

• Heart failure rehospitalization

  after the procedure.

Other Outcomes (1)

• Atrial fibrillation effects on quality-of-life (AFEQT) scores

  at baseline and after the procedure

Study Arms (1)

LAAC plus Catheter ablation

Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.

Procedure: left atrial appendage closure and catheter ablation

Interventions

left atrial appendage closure and catheter ablation PROCEDURE

Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF). Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.

Also known as: left atrial appendage occlusion; radiofrequency ablation

LAAC plus Catheter ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation 2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs; 3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation 4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3 5. Provide informed consent to participate in the study; 6. Between 18-90 years

You may qualify if:

• History of paroxysmal/persistent/longstanding persistent atrial fibrillation
• Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
• With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
• CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
• Provide informed consent to participate in the study;
• Between 18-90 years

You may not qualify if:

• myocardial infarction within 3 months
• Stroke or systemic embolism within 3 months
• Plan to receive heart transplantation;
• Life expectancy less than 1 year;
• Severe bleeding diseases that cannot be treated with short-term anticoagulants;
• With left atrial or left atrial appendage thrombus;
• With uncontrolled malignant tumor ;
• Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr \<50%);
• Women who are pregnant, or breastfeeding.
• Other conditions not suitable to the combined procedure.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (17)

• Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.

  PMID: 23982711 RESULT

• Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc. 2015 Jan 21;4(1):e001486. doi: 10.1161/JAHA.114.001486.

  PMID: 25609415 RESULT

• Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.

  PMID: 9737513 RESULT

• Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.

  PMID: 12401529 RESULT

• Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.

  PMID: 23321349 RESULT

• Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.

  PMID: 27029350 RESULT

• Hu H, Cui K, Jiang J, Fu H, Zeng R. Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation. Pacing Clin Electrophysiol. 2018 Jan;41(1):28-34. doi: 10.1111/pace.13250. Epub 2017 Dec 28.

  PMID: 29194654 RESULT

• Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.

  PMID: 29106523 RESULT

• Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm. 2004 Nov;1(5):576-81. doi: 10.1016/j.hrthm.2004.07.020.

  PMID: 15851222 RESULT

• Perea RJ, Tamborero D, Mont L, De Caralt TM, Ortiz JT, Berruezo A, Matiello M, Sitges M, Vidal B, Sanchez M, Brugada J. Left atrial contractility is preserved after successful circumferential pulmonary vein ablation in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2008 Apr;19(4):374-9. doi: 10.1111/j.1540-8167.2007.01086.x. Epub 2008 Feb 4.

  PMID: 18266672 RESULT

• Luani B, Groscheck T, Genz C, Tanev I, Rauwolf T, Herold J, Medunjanin S, Schmeisser A, Braun-Dullaeus RC. Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN-device. BMC Cardiovasc Disord. 2017 Dec 12;17(1):294. doi: 10.1186/s12872-017-0728-6.

  PMID: 29233088 RESULT

• Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.

  PMID: 24998121 RESULT

• Chen M, Yao PC, Fei ZT, Wang QS, Yu YC, Zhang PP, Li W, Zhang R, Mo BF, Zhao MZ, Yu Y, Yang M, Zhao Y, Gong CQ, Sun J, Li YG. Prognostic Impact of Left Atrial Appendage Patency After Device Closure. Circ Cardiovasc Interv. 2024 May;17(5):e013579. doi: 10.1161/CIRCINTERVENTIONS.123.013579. Epub 2024 Apr 17.

  PMID: 38629273 DERIVED

• Yao PC, Fei ZT, Chen M, Mo BF, Zhang R, Yang YL, Sun J, Wang QS, Li YG. Incidence, impact and predictors of residual device patency after left atrial appendage closure with the LACbes device. Int J Cardiol. 2024 Feb 15;397:131640. doi: 10.1016/j.ijcard.2023.131640. Epub 2023 Dec 6.

  PMID: 38065326 DERIVED

• Fei Z, Liu M, Yao P, Zhao M, Gong C, Chen M, Fei Y, Mo B, Zhang R, Yu Y, Yang Y, Wang Q, Li W, Zhang P, Sun J, Wang Q, Li Y. Effect of combined catheter ablation of atrial fibrillation and left atrial appendage closure on left atrial structure compared with a single procedure. Chin Med J (Engl). 2023 Dec 20;136(24):3010-3012. doi: 10.1097/CM9.0000000000002746. Epub 2023 Jun 26. No abstract available.

  PMID: 37365140 DERIVED

• Chen M, Sun J, Li W, Zhang PP, Zhang R, Mo BF, Yang M, Wang QS, Li YG. Sex Differences in the Combined Ablation and Left Atrial Appendage Closure: Results From LAACablation Registry. JACC Asia. 2023 Jan 17;3(1):138-149. doi: 10.1016/j.jacasi.2022.10.011. eCollection 2023 Feb.

  PMID: 36873751 DERIVED

• Yang M, Chen M, Gong CQ, Li W, Zhang PP, Zhang R, Mo BF, Ding HR, Wang QS, Lu QF, Sun J, Li YG. Left atrial appendage closure in patients with reversed chicken-wing morphology: Anatomical features and procedural strategy. Heliyon. 2023 Jan 3;9(1):e12662. doi: 10.1016/j.heliyon.2022.e12662. eCollection 2023 Jan.

  PMID: 36691523 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will only harvest whole blood to determine the biomarkers of heart failure and inflammation in the plasma. The investigators will not retain any tissue or other specimens or extract DNA from tissues or plasma.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure; Catheter Ablation; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yi-Gang Li, Dr.

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu Chen, Dr.

CONTACT

86 021 25077275; chenmu@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 28, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 19, 2023

Record last verified: 2022-10

Locations

CN (1)