Clinical trial

Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

Opening soon · Not applicable · 1 countries · Registry ID NCT07382024

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionAtrial Fibrillation Ablation, Persistent Atrial Fibrillation, Obesity & Overweight

Full registry criteria

Inclusion Criteria: 1. Age between 18 and 80 years. 2. Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation. 3. Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes). 4. Able and willing to provide written informed consent. Exclusion Criteria: 1. Long-standing AF or marked left atrial enlargement (persistent AF duration \> 5 years or left atrial anterior-posterior diameter \> 50 mm). 2. AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery). 3. Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy). 4. Planned major non-AF-related surgery or interventional procedure within 3 months. 5. Other arrhythmias requiring chronic antiarrhythmic drug therapy. 6. Intracardiac thrombus or any contraindication to catheter ablation as judged by the investigator. 7. Active systemic infection at screening. 8. 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). 9. Poorly controlled type 1 diabetes, recent diabetic ketoacidosis, end-stage renal disease requiring dialysis, or severe hepatic dysfunction judged clinically significant. 10. Pregnancy, breastfeeding, or women of childbearing potential unwilling or unable to use adequate contraception during the study. 11. Participation in another interventional clinical study within 30 days prior to screening or planned participation during the study period. 12. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation, including inability to comply with study procedures or follow-up.

Treatments and study arms

Tirzepatide

Drug

Subcutaneous tirzepatide 2.5 mg once weekly, initiated approximately 4 weeks before the scheduled de novo catheter ablation and continued for 3 months after the procedure (total treatment duration about 4 months), in addition to standard peri-procedural and post-ablation care.

Standard Care (in control arm)

Other

Standard peri-procedural and post-ablation care for persistent atrial fibrillation without tirzepatide or other study-specific metabolic pharmacotherapy.

Primary outcomes

Atrial fibrillation burden at 3 months after catheter ablation3 months after catheter ablation (7-day ECG patch monitoring period)

AF burden is defined as the proportion of time an individual is in any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) during a 7-day monitoring period, assessed using continuous single-lead ECG patch recordings. AF burden will be adjudicated by a blinded Endpoint Assessment Committee based on de-identified ECG data.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Taiwan University Hospital Cardiovascular Center🇹🇼 Taipei, Taiwan

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