Left Atrial Appendage Closure in Combination With Catheter Ablation

Atrial Fibrillation Clinical Trial

— LAACablation  

Official title:

The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788941
• Other study ID #: XH-18-015
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Mu Chen, Dr.
• Phone: 86 021 25077275
• Email: chenmu[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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:

1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.

2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.

3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. myocardial infarction within 3 months

2. Stroke or systemic embolism within 3 months

3. Plan to receive heart transplantation;

4. Life expectancy less than 1 year;

5. Severe bleeding diseases that cannot be treated with short-term anticoagulants;

6. With left atrial or left atrial appendage thrombus;

7. With uncontrolled malignant tumor ;

8. Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr <50%);

9. Women who are pregnant, or breastfeeding.

10. Other conditions not suitable to the combined procedure.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• left atrial appendage closure and catheter ablation
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.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (12)

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 — View Citation

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. — View Citation

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. — View Citation

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, — View Citation

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 Ja — View Citation

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 — View Citation

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. — View Citation

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. He — View Citation

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 append — View Citation

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 — View Citation

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 re — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	at baseline and after the procedure
Primary	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.
Primary	Major bleeding	The incidence of major bleeding in the participants will be reported.	long-term after the procedure.
Primary	Death	all-cause death	long-term after the procedure.
Secondary	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
Secondary	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.
Secondary	Heart failure rehospitalization	acute heart failure leading to hospitalization	after the procedure.