Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

Sponsor
National Taiwan University Hospital
Study ID
NCT07382024
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation Ablation
  • Obesity & Overweight
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Care（Intervention: Other - standard care / no tirzepatide）
  • Active Comparator: Tirzepatide + Standard Care（Intervention: Drug - tirzepatide）

Primary Outcome Measure

Atrial fibrillation burden at 3 months after catheter ablation [ Time Frame: 3 months after catheter ablation (7-day ECG patch monitoring period) ]

Central Contacts

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