TEAR-AF

Not yet recruitingPhase 4

Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients

Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients: A Multicenter, Randomized, Open-Label Trial

Lead sponsor

Yunlong Wang

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

710

Study population

Atrial fibrillation, Cardiovascular disease, Obesity / overweight

Eligibility highlights

•BMI ≥28

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07715929

Org study IDTEAR-AF-01

Timeline

Milestones

Study first posted2026-07-21actual

Last update posted2026-07-21actual

Study start2026-09-01estimated

Primary completion2029-09-01estimated

Study completion2029-12-30estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Atrial fibrillationCardiovascular diseaseObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.