Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years.
Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).
Able and willing to provide written informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugSubcutaneous 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 interventionStandard peri-procedural and post-ablation care for persistent atrial fibrillation without tirzepatide or other study-specific metabolic pharmacotherapy.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard Care（Intervention: Other - standard care / no tirzepatide）Active comparator 1 intervention
Group B: Tirzepatide + Standard Care（Intervention: Drug - tirzepatide）Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Atrial fibrillation burden at 3 months after catheter ablation
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.
Time frame
3 months after catheter ablation (7-day ECG patch monitoring period)Secondary outcomes
1
Atrial fibrillation recurrence within 3 months after catheter ablation
AF recurrence is defined as the first documented episode of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, detected by ECG monitoring or clinically indicated ECG during the first 3 months after ablation. Episodes occurring within a standard blanking period, if applicable, will be handled according to the study protocol.
Time frame
From the date of ablation to 3 months after ablation2
Change in left atrial structure by echocardiography at 3 months
Change from baseline to 3 months in echocardiographic measures of left atrial structure (left atrial volume indices), assessed by transthoracic echocardiography according to standard guidelines.
Time frame
Baseline and 3 months after ablation3
Change in atrial fibrillation-related quality of life questionnaire
Change from baseline to 3 months in health-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, using a validated Chinese version for Chinese-speaking participants. Higher scores indicate better quality of life.
Time frame
Baseline and 3 months after ablation4
Atrial fibrillation recurrence within 12 months after catheter ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, detected by ECG or rhythm monitoring during 12 months of follow-up after ablation.
Time frame
From the date of ablation to 12 months after ablationSponsors and contacts
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Source ClinicalTrials.gov
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