Actively Recruiting
Randomized Controlled Trial Comparing Catheter Ablation Combined With Left Atrial Appendage Occlusion Versus Catheter Ablation With Oral Anticoagulation in Frail Elderly Patients With Atrial Fibrillation
Led by Guangdong Provincial People's Hospital · Updated on 2026-06-08
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
A
Abbott (China)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is a common heart rhythm disorder that greatly increases the risk of stroke, heart failure, hospitalization, and death. This research aims to compare two treatment approaches for elderly AF patients who are frail and have a high risk of bleeding. The study evaluates catheter ablation combined with left atrial appendage occlusion (LAAO) against catheter ablation combined with long-term oral anticoagulation (OAC), addressing a current gap in evidence about the best strategy for this vulnerable group. Participants will be randomly assigned to one of two groups: one receiving catheter ablation plus LAAO, a device-based procedure to prevent stroke, and the other receiving catheter ablation plus standard oral anticoagulation therapy. The LAAO procedure may be done during the ablation session or separately. After LAAO, participants receive anticoagulation for 90 days, followed by possible de-escalation based on imaging results. The other group continues guideline-directed anticoagulation after ablation. Both groups are closely monitored for safety and effectiveness. During the 24-month study, participants will undergo regular assessments including ECGs, Holter monitoring to track heart rhythm, and imaging tests to evaluate heart function and device status. Researchers will measure outcomes such as stroke, bleeding events, death, AF recurrence, and quality of life. Additional evaluations include frailty scores, cognitive function, and daily living activities. The study also monitors procedural success, hospital stay length, and complications to help determine which treatment better supports elderly patients with AF.
CONDITIONS
Brief Title
Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 75 years or older
- Confirmed diagnosis of non-valvular atrial fibrillation (paroxysmal or persistent)
- CHA2DS2-VASc score of 3 or higher indicating high stroke risk
- Either have had catheter ablation for AF within 90 to 180 days before randomization or are scheduled for ablation within 10 days after randomization
- Able to tolerate the antithrombotic drug regimen as judged by the investigator
- Suitable for transesophageal echocardiography (TEE) or pulmonary vein CT
- Able and willing to provide written informed consent
- Willing to attend all scheduled follow-up visits and examinations
You will not qualify if you...
- Presence of blood clot in the left atrium or left atrial appendage on imaging
- Major bleeding event within 14 days prior to randomization, especially if ongoing or planned interventions
- Need for long-term oral anticoagulation for reasons other than stroke prevention in AF
- Cardiac or major non-cardiac surgery (excluding AF ablation and cardioversion) within 30 days before or scheduled within 60 days after randomization
- Life expectancy less than 2 years, cancer, infectious endocarditis, uncontrolled infection, or cardiac tamponade
- Clinical Frailty Scale score of 1-3 (not frail) or 7-9 (severely frail/terminally ill)
- Unsuitable for long-term anticoagulation or antiplatelet therapy due to bleeding risk or allergies
- Current participation in another clinical trial that conflicts with this study
- Stroke or transient ischemic attack within 60 days prior to randomization
- Heart attack within 90 days prior to randomization
- History of atrial septal defect repair or presence of an atrial septal occluder device
- Presence of any mechanical heart valve
- Pregnancy or planning pregnancy during the study period
- Medical or anatomical reasons preventing catheter-based interventions
- Severe heart failure (NYHA Class IV)
- History of surgical left atrial appendage closure
- Left ventricular ejection fraction below 30%
- Significant pericardial effusion
- High-risk patent foramen ovale with atrial septal aneurysm or large shunt
- Moderate or severe mitral valve narrowing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days (index hospitalization)
Participants undergo catheter ablation with or without Left Atrial Appendage Occlusion (LAAO) as assigned, followed by antithrombotic management including oral anticoagulation. The treatment includes the procedure and immediate post-procedure care during hospitalization.
1 procedure and hospital stay
Duration - 24 months
Participants attend scheduled follow-up visits for efficacy and safety monitoring, including ECGs, Holter monitoring, and imaging studies to assess heart rhythm, device stability, and complications. Antithrombotic therapy adjustments may occur based on imaging results.
Visits at 1, 3, 6, 12, and 24 months post-procedure
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
Y
Yumei Xue, M.D.
J
Junrong Jiang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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