Left Atrial Appendage Closure in Combination With Catheter Ablation

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: left atrial appendage closure and catheter ablation

• Registration Number: NCT03788941
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-28
• Status Verified: 2022-10
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAAC plus Catheter ablation	left atrial appendage closure and catheter ablation	Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.

Primary Outcome Measures

Name	Time	Method
Major bleeding	long-term after the procedure.	The incidence of major bleeding in the participants will be reported.
stroke/TIA/systemic embolism	long-term after the procedure.	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.
Death	long-term after the procedure.	all-cause death

Secondary Outcome Measures

Name	Time	Method
procedure-related complications	after the procedure.	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.
Heart failure rehospitalization	after the procedure.	acute heart failure leading to hospitalization
maintenance of sinus rhythm	after the procedure outside the 3-month blanking period	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.

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China