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Trial · Interventional

Not yet recruitingPhase 4Registry data

Effect 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
20262027202820292030
  1. Ph 4

    TEAR-AF

    NCT07715929

    est. 1 Sept 2026 to est. 30 Dec 2029

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.

  1. 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)
  1. 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.

  2. 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.

  3. Change in BMI

    Time frame · Baseline to Week 52

    Registry description

    Change from baseline to 52 weeks in body mass index (kg/m²)

  4. Change in waist circumference

    Time frame · Baseline to Week 52

    Registry description

    Change from baseline to 52 weeks waist circumference (cm).

  5. 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.

  6. 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.

  7. 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.

  8. Time to Cardiovascular Death

    Time frame · Day 1 through Week 52

    Registry description

    Time to cardiovascular death.

  9. 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
Inclusion Criteria: * Age ≥18 years and ≤75 years at the time of screening * Documented symptomatic paroxysmal AF or persistent AF, confirmed by 12-lead ECG, Holter monitoring, or cardiac monitoring device, with documented AF episode duration ≥7 days (for persistent AF) and total AF history duration ≤5 years * Body weight criteria (aligned with NMPA-approved tirzepatide indication) meeting at least one of the following: BMI ≥28.0 kg/m² (obesity threshold per Chinese criteria), OR BMI ≥24.0 kg/m² and \<28.0 kg/m² (overweight per Chinese criteria) with at least one weight-related comorbidity: hypertension, dyslipidemia, type 2 diabetes mellitus (T2DM), obstructive sleep apnea syndrome (OSAS), or atherosclerotic cardiovascular disease (ASCVD) * Failed response to or intolerance of at least one antiarrhythmic drug (AAD), or explicit patient preference for a rhythm control strategy * Undergoing catheter ablation for AF at a participating center, with confirmed successful restoration of sinus rhythm at the end of the procedure (as determined by the operator) * Willing and able to understand the study procedures, provide written informed consent, and comply with all protocol requirements including 12-month follow-up visits * Capable of performing basic physical activity (no absolute contraindication to moderate-intensity aerobic exercise) Exclusion Criteria: Cardiovascular Exclusion Criteria * Long-standing persistent AF: continuous AF duration ≥5 years prior to enrollment * Prior catheter ablation for AF or atrial flutter at any time * Left atrial anteroposterior diameter \>55 mm (by transthoracic echocardiography at screening) * Left ventricular ejection fraction (LVEF) \<35% at screening * NYHA functional class III or IV heart failure * Significant structural heart disease: hypertrophic cardiomyopathy, valvular heart disease requiring intervention, congenital heart disease, myocarditis, or cardiac sarcoidosis * Acute coronary syndrome (ACS), ischemic stroke/TIA, or major cardiac surgery within 6 months prior to screening Tirzepatide-Specific Exclusion Criteria (per NMPA Prescribing Information) * Prior use of any GLP-1 receptor agonist (liraglutide, semaglutide, dulaglutide, exenatide, etc.) or GIP receptor agonist, or known hypersensitivity to tirzepatide or any excipient in the formulation * Personal or family (first-degree relative) history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) * History of acute pancreatitis or chronic pancreatitis, or current symptomatic cholelithiasis or cholecystitis * Type 1 DM * Severe gastrointestinal disease including severe gastroparesis, inflammatory bowel disease, or any condition that would substantially impair gastrointestinal motility or absorption General Exclusion Criteria * Use of any weight-loss medication (orlistat, phentermine, naltrexone/bupropion, or other anti-obesity agents) or participation in any weight-loss pharmacotherapy clinical trial within 3 months prior to screening * Severe hepatic insufficiency (Child-Pugh class C) or severe renal insufficiency (eGFR \<15 mL/min/1.73 m²) * Active malignancy (receiving systemic anti-cancer treatment or with life expectancy \<2 years due to malignancy) * Pregnancy, breastfeeding, or women of childbearing potential who are unwilling to use highly effective contraception throughout the study and for ≥1 month after the last dose of tirzepatide * Severe psychiatric disorder (schizophrenia, bipolar disorder, severe major depressive disorder) that would impair ability to comply with study procedures * Known allergy or sensitivity to adhesive patch materials (relevant to ECG monitoring patch components) * Any other condition that, in the opinion of the investigator, would make participation inadvisable or compromise the safety of the participant or the integrity of the study

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