Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation (NCT07382024) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
Taiwan200 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population.
The main questions it aims to answer are:
1. Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring?
2. Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone?
3. Does tirzepatide reduce AF recurrence and cardiovascular events during 12 months of follow-up? Researchers will conduct a multi-center, open-label, endpoint-blinded, randomized controlled trial in adults aged 18-80 years with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants will be randomized 1:1 to receive either tirzepatide plus standard peri-procedural and post-ablation care or standard care alone.
Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years.
✓. Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
✓. Body mass index (BMI) ≥ 25 kg/m² at screening.
✓. Able and willing to provide written informed consent.
Exclusion criteria
✕. Long-standing AF or marked left atrial enlargement (persistent AF duration \> 5 years or left atrial anterior-posterior diameter \> 50 mm).
✕. AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery).
✕. Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy).
✕. Planned major non-AF-related surgery or interventional procedure within 3 months.
✕. Other arrhythmias requiring chronic antiarrhythmic drug therapy.
What they're measuring
1
Atrial fibrillation burden at 3 months after catheter ablation
✕. Intracardiac thrombus or any contraindication to catheter ablation as judged by the investigator.
✕. Active systemic infection at screening.
✕. Contraindications to tirzepatide or GLP-1/GIP receptor agonists (e.g., prior serious hypersensitivity, personal or family history of medullary thyroid carcinoma or MEN2, history of clinically significant pancreatitis, severe gastrointestinal disease that may impair tolerance or absorption).