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NOT YET RECRUITING
NCT07382024
NA

Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of Tirzepatide on Weight Loss and Atrial Fibrillation Burden After Catheter Ablation in Overweight or Obese Patients

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-05-01

Completion Date

2028-07-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

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.

OTHER

Standard Care (in control arm)

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

Locations (1)

National Taiwan University Hospital Cardiovascular Center

Taipei, Taiwan