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Safety and effectiveness of cardiac catheter ablation combined with left atrial appendage occlusion for the treatment of non-valvular atrial fibrillation

Safety and effectiveness of cardiac catheter ablation combined with left atrial appendage occlusion for the treatment of non-valvular atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092667
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-25
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

Treatment group 1:radiofrequency ablation combined with left atrial appendage occlusion
Treatment group 2:cryoballoon ablation combined with left atrial appendage occlusion
Treatment group 3:Pulsed electric field ablation combined with left atrial appendage occlusion

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18 years old = 2, female CHADS2 score >= 3, and long-term oral anticoagulant therapy contraindications); 4) Symptomatic patients have poor efficacy or intolerance to at least one type I or III antiarrhythmic drug treatment; 5) Fully understand the treatment plan and voluntarily sign an informed consent form, willing to undergo the required examinations, surgeries, and follow-up as per the plan.

Exclusion criteria

Exclusion criteria: 1) Patients who experience recurrence after rapid atrial fibrillation ablation; 2) Left atrial thrombus or suspected thrombus; 3) Patients with valvular atrial fibrillation; 4) Clearly merge upper room speed and atrial flutter; 5) Patients of childbearing age who cannot take effective contraceptive measures within 12 months after enrollment; 6) Left atrial anterior posterior diameter >= 65mm; 7) Left ventricular ejection fraction (LVEF) <= 35%; 8) Previously underwent atrial septal repair surgery; 9) Expected lifespan <= 1 year; 10) Cannot tolerate left atrial appendage occlusion surgery; 11) The shape of the left atrial appendage is not suitable for placing an occluder; 12) Patients with pericardial effusion of more than 10mm in the heart or posterior wall, and the cause is unknown; 13) Other diseases that require long-term anticoagulant therapy besides atrial fibrillation (such as spontaneous or recurrent venous thromboembolism after mechanical valve replacement surgery); 14) Presence of rheumatic heart valve disease, mitral stenosis (valve area<1.5 cm2), or mechanical valve replacement surgery; 15) Carrying active implants in the body (such as pacemakers, ICDs, etc.); 16) Heart function NYHA class III-IV; 17) Individuals with clear cerebrovascular disease (including cerebral hemorrhage, stroke, and transient ischemic attack) within the past 6 months; 18) Individuals who have experienced cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, artificial valve replacement or repair, atrial or ventricular incision); 19) Individuals with acute or severe systemic infections; 20) The researchers believe that the combination of severe liver and kidney diseases, malignant tumors, and end-stage disease patients may interfere with the treatment, evaluation, and compliance of this trial; 21) Individuals with obvious bleeding tendency, high coagulation state, and severe hematological disorders; 22) Patients who have participated or are currently participating in other clinical trials within the past 3 months prior to enrollment; 23) Patients who other researchers believe are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Immediate success rate of surgery;

Secondary

MeasureTime frame
Long term success rate of surgery;

Countries

China

Contacts

Public ContactHongde Hu

Department of Cardiology, West China Hospital, Sichuan University

huhongde@vip.163.com+86 189 8060 1232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026