Atrial FibrillationPhase 4TEAR-AFNCT07715929
Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients
A Phase 4 study testing Tirzepatide and Structured Lifestyle Intervention in people with Atrial Fibrillation and Obesity & Overweight, run by Yunlong Wang.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Obesity & Overweight, Catheter Ablation
- What is being tested?
- Tirzepatide and Structured Lifestyle Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
About this study
Official title: Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients: A Multicenter, Randomized, Open-Label Trial
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.
Read the detailed description
Eligible obese patients (or overweight patients with a weight-related comorbidity) with symptomatic paroxysmal or persistent AF undergoing catheter ablation will be screened within 28 days before the procedure. After ablation with restoration of sinus rhythm, participants will be randomized 1:1 to (a) tirzepatide plus standardized lifestyle intervention and standard AF management, or (b) standardized lifestyle intervention and standard AF management alone. Randomization is stratified by study center, AF type (paroxysmal/persistent), baseline BMI, and diabetes status.
A 90-day post-ablation blanking period (Day 0-90) is excluded from the primary efficacy assessment. The primary efficacy assessment window runs from Day 91 to Day 365. Tirzepatide is administered subcutaneously once weekly and titrated per the China NMPA label using an individualized dose-adjustment SOP, continuing through Week 52. Both groups receive guideline-directed periprocedural anticoagulation, standardized antiarrhythmic drug (AAD) use, an individualized exercise prescription, a modified Mediterranean diet (target intake = total energy expenditure - 500 kcal), and management of smoking, alcohol, comorbidities, sleep, and obstructive sleep apnea (OSA).
Approximately 8-12 tertiary (Class 3A) hospitals in China with mature AF ablation teams will participate. Planned enrollment is 710 participants.
- Conditions
- Atrial Fibrillation, Obesity & Overweight, Catheter Ablation
- Being tested
- Tirzepatide, Structured Lifestyle Intervention
- Keywords
- Atrial Fibrillation, Tirzepatide, GIP/GLP-1 receptor agonist
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro
Dual GIP and GLP-1 receptor agonist administered as a weekly subcutaneous injection.
Titrated from 2.5 mg/week to a target of 10 mg/week over 12 weeks, then maintained at the maximum tolerated dose for the remainder of the 52-week treatment period.
Structured Lifestyle InterventionBehavioural
Guideline-directed AF management (rate/rhythm control, anticoagulation by CHA2DS2-VASc).
Structured lifestyle intervention: 500 kcal/day caloric deficit; exercise prescription of ≥150 min/week moderate aerobic; smoking cessation and alcohol moderation counseling.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide + Lifestyle Intervention | Experimental | 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) Receives: Drug: Tirzepatide; Behavioral: Structured Lifestyle Intervention |
| Lifestyle Intervention | Active comparator | 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 Receives: Behavioral: Structured Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia
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.
Measured: Day 91 through Week 52 after catheter ablation
Secondary outcomes (9)
Percentage of Monitoring Time Spent in Atrial Fibrillation (AF Burden)
Percentage of total monitoring time spent in AF, measured by 7-day ambulatory ECG patch.
Measured: At Week 12, Week 26, and Week 52
Change in body weight
Absolute and percentage change in body weight from baseline to baseline to 52 weeks.
Measured: Baseline to Week 52
Change in BMI
Change from baseline to 52 weeks in body mass index (kg/m²)
Measured: Baseline to Week 52
Change in waist circumference
Change from baseline to 52 weeks waist circumference (cm).
Measured: Baseline to Week 52
Change in left atrial volume index (LAVI)
Change in echocardiographic LAVI (mL/m²) from baseline to 52 weeks measured by core laboratory.
Measured: Baseline to Week 52
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Change in serum NT-proBNP concentration from baseline to 52 weeks, measured by central laboratory.
Measured: Baseline to Week 52
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to 52 weeks, measured by central laboratory.
Measured: Baseline to Week 52
Time to Cardiovascular Death
Time to cardiovascular death.
Measured: Day 1 through Week 52
Time to Death From Any Cause
Time to death from any cause.
Measured: Day 1 through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunlong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunlong Wang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715929
- Sponsor's protocol ID
- TEAR-AF-01
- Acronym
- TEAR-AF
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data underlying the published results, together with the study protocol, statistical analysis plan, and data dictionary, will be made available upon reasonable request after publication of the primary results.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients: A Multicenter, Randomized, Open-Label Trial
- ClinicalTrials.gov ID
- NCT07715929
- Acronym / sponsor ID
- TEAR-AF / TEAR-AF-01
- Conditions
- Atrial Fibrillation, Obesity & Overweight, Catheter Ablation
- Keywords
- Atrial Fibrillation, Tirzepatide, GIP/GLP-1 receptor agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Yunlong WangUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible obese patients (or overweight patients with a weight-related comorbidity) with symptomatic paroxysmal or persistent AF undergoing catheter ablation will be screened within 28 days before the procedure. After ablation with restoration of sinus rhythm, participants will be randomized 1:1 to (a) tirzepatide plus standardized lifestyle intervention and standard AF management, or (b) standardized lifestyle intervention and standard AF management alone. Randomization is stratified by study center, AF type (paroxysmal/persistent), baseline BMI, and diabetes status.
A 90-day post-ablation blanking period (Day 0-90) is excluded from the primary efficacy assessment. The primary efficacy assessment window runs from Day 91 to Day 365. Tirzepatide is administered subcutaneously once weekly and titrated per the China NMPA label using an individualized dose-adjustment SOP, continuing through Week 52. Both groups receive guideline-directed periprocedural anticoagulation, standardized antiarrhythmic drug (AAD) use, an individualized exercise prescription, a modified Mediterranean diet (target intake = total energy expenditure - 500 kcal), and management of smoking, alcohol, comorbidities, sleep, and obstructive sleep apnea (OSA).
Approximately 8-12 tertiary (Class 3A) hospitals in China with mature AF ablation teams will participate. Planned enrollment is 710 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide + Lifestyle Intervention | Experimental | Drug: Tirzepatide, Behavioral: Structured Lifestyle InterventionStandardized 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) |
| Lifestyle Intervention | Active comparator | Behavioral: Structured Lifestyle InterventionAF 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: MounjaroDual GIP and GLP-1 receptor agonist administered as a weekly subcutaneous injection. Titrated from 2.5 mg/week to a target of 10 mg/week over 12 weeks, then maintained at the maximum tolerated dose for the remainder of the 52-week treatment period. | Drug | Tirzepatide + Lifestyle Intervention |
| Structured Lifestyle InterventionGuideline-directed AF management (rate/rhythm control, anticoagulation by CHA2DS2-VASc). Structured lifestyle intervention: 500 kcal/day caloric deficit; exercise prescription of ≥150 min/week moderate aerobic; smoking cessation and alcohol moderation counseling. | Behavioural | Lifestyle Intervention, Tirzepatide + Lifestyle Intervention |
Primary outcome
Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia
Time frame: Day 91 through Week 52 after catheter ablation
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.
9 secondary outcomes
Percentage of Monitoring Time Spent in Atrial Fibrillation (AF Burden)
Time frame: At Week 12, Week 26, and Week 52
Change in body weight
Time frame: Baseline to Week 52
Change in BMI
Time frame: Baseline to Week 52
Change in waist circumference
Time frame: Baseline to Week 52
Change in left atrial volume index (LAVI)
Time frame: Baseline to Week 52
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline to Week 52
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: Baseline to Week 52
Time to Cardiovascular Death
Time frame: Day 1 through Week 52
Time to Death From Any Cause
Time frame: Day 1 through Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data underlying the published results, together with the study protocol, statistical analysis plan, and data dictionary, will be made available upon reasonable request after publication of the primary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide and Structured Lifestyle Intervention in people with Atrial Fibrillation and Obesity & Overweight, run by Yunlong Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia (time frame: Day 91 through Week 52 after catheter ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.