Trial · Interventional
Not yet recruitingPhase 4Registry dataEffect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients
Short name TEAR-AF
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 710 participants (estimated)
- Sponsor
- Yunlong Wang · Other
- Design
- Randomized · Single masking
- Countries
- Not stated
- Start
- 1 Sept 2026 (estimated)
- Primary completion
- 1 Sept 2029 (estimated)
- Completion
- 30 Dec 2029 (estimated)
- First posted
- 21 Jul 2026
- Last update posted
- 21 Jul 2026
- Conditions
- Atrial Fibrillation · Obesity & Overweight · Catheter Ablation
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Obese patients with atrial fibrillation (AF) have a high recurrence rate after catheter ablation, even at experienced centers. Weight reduction improves post-ablation outcomes, but lifestyle measures alone are difficult to sustain. Tirzepatide, a once-weekly GIP/GLP-1 dual receptor agonist, produces greater weight loss than GLP-1 monotherapy and may confer additional cardiometabolic benefits. This multicenter, randomized, open-label, parallel-group, superiority trial evaluates whether adding standardized tirzepatide treatment to a structured lifestyle intervention - compared with the lifestyle intervention alone - reduces AF recurrence within 1 year after ablation in obese patients.
Interventions
- TirzepatideDrug
- Structured Lifestyle InterventionBehavioral
Arms2
Experimental
Tirzepatide + Lifestyle Intervention
Standardized lifestyle intervention and standard AF management plus once-weekly subcutaneous tirzepatide, initiated after randomization and continued through Week 52. Tirzepatide titration (per NMPA label): * Weeks 1-4: 2.5 mg once weekly (initiation) * Weeks 5-16: escalate by 2.5 mg every 4 weeks (5 mg → 7.5 mg → 10 mg) * Weeks 17-52: maintenance 10 mg once weekly, up-titratable to 15 mg (maximum dose 15 mg)
Active comparator
Lifestyle Intervention
AF Management and Post-Ablation Care * Ablation technique: circumferential pulmonary vein isolation (CPVI) ± adjunctive linear ablation at operator discretion, using established mapping and energy delivery protocols * Peri-procedural anticoagulation: guideline-directed anticoagulation * Antiarrhythmic drug (AAD) use: standardized per protocol SOP; Exercise Intervention • Target: moderate-intensity aerobic exercise ≥150 minutes per week, OR vigorous-intensity aerobic exercise ≥75 minutes per week Dietary Intervention • Caloric target: estimated total energy expenditure (TEE) minus 500 kcal/day Other Risk Factor Management * Smoking cessation * Alcohol restriction * Comorbidity management * OSA management
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia
Time frame · Day 91 through Week 52 after catheter ablation
Registry description
Any documented atrial arrhythmia - defined as AF, atrial flutter (AFL), or atrial tachycardia (AT) - lasting ≥30 seconds, in the absence of antiarrhythmic drug (AAD) use.
Secondary outcomes(9)
Percentage of Monitoring Time Spent in Atrial Fibrillation (AF Burden)
Time frame · At Week 12, Week 26, and Week 52
Registry description
Percentage of total monitoring time spent in AF, measured by 7-day ambulatory ECG patch.
Change in body weight
Time frame · Baseline to Week 52
Registry description
Absolute and percentage change in body weight from baseline to baseline to 52 weeks.
Change in BMI
Time frame · Baseline to Week 52
Registry description
Change from baseline to 52 weeks in body mass index (kg/m²)
Change in waist circumference
Time frame · Baseline to Week 52
Registry description
Change from baseline to 52 weeks waist circumference (cm).
Change in left atrial volume index (LAVI)
Time frame · Baseline to Week 52
Registry description
Change in echocardiographic LAVI (mL/m²) from baseline to 52 weeks measured by core laboratory.
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame · Baseline to Week 52
Registry description
Change in serum NT-proBNP concentration from baseline to 52 weeks, measured by central laboratory.
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame · Baseline to Week 52
Registry description
Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to 52 weeks, measured by central laboratory.
Time to Cardiovascular Death
Time frame · Day 1 through Week 52
Registry description
Time to cardiovascular death.
Time to Death From Any Cause
Time frame · Day 1 through Week 52
Registry description
Time to death from any cause.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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