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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.
This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.
This study will be conducted in accordance with the following procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAAC plus Catheter ablation | Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| maintenance of sinus rhythm | This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias. | after the procedure outside the 3-month blanking period |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation effects on quality-of-life (AFEQT) scores | At baseline and at the 1-year follow-up visit, patients were required to complete a 20-item questionnaire based on the AF effects on quality-of-life (QoL) (AFEQT, http://www.afeqt.org) measure. The 20-item AFEQT survey evaluated 4 domains regarding the QoL assessment and the perception of treatment, i.e., symptoms, daily activities, treatment-related concerns, and treatment satisfaction. The first three domains constituted the global score. The scores of each individual domain and the global score ranged between 0 and 100, with "100" representing the best health status and "0" being the worst health status possible. A validated culturally and linguistically translated version of the AFEQT for China was used. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Chen, Dr. | Contact | 86 021 25077275 | chenmu@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Gang Li, Dr. | Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23982711 | Result | 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. | |
| 25609415 | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| D017115 | Catheter Ablation |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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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.
|
|
| procedure-related complications |
These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications. |
| after the procedure. |
| Heart failure rehospitalization | acute heart failure leading to hospitalization | after the procedure. |
| at baseline and after the procedure |
| 9737513 | 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. |
| 12401529 | 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. |
| 23321349 | 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. |
| 27029350 | 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. |
| 29194654 | 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. |
| 29106523 | 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. |
| 15851222 | 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. |
| 18266672 | 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. |
| 29233088 | 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. |
| 24998121 | 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. |
| 42294778 | Derived | Yao PC, Chen M, Wang QS, Yang M, Zhang R, Zhang PP, Li W, Zhao Y, Lian XM, Wang Q, Fei YD, Wei ZX, Yang XM, Cai XX, Sun J, Li YG. Left Atrial Appendage Electrical Isolation Reduces Residual Patency After Device Closure in Patients With Persistent Atrial Fibrillation. J Am Heart Assoc. 2026 Jun 15:e046374. doi: 10.1161/JAHA.125.046374. Online ahead of print. |
| 38629273 | Derived | 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. |
| 38065326 | 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. |
| 37365140 | 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. |
| 36873751 | 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. |
| 36691523 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000078702 |
| Radiofrequency Therapy |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |