DelfaGLP-1 Atlas

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TREAT-AF

Not yet recruitingPhase NA

Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

Tirzepatide to Reduce Recurrence and Burden After Catheter Ablation of Atrial Fibrillation: A Prospective Randomized Trial

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

200

estimated

Study population

Atrial fibrillation, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Atrial fibrillation burden

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07382024
Org study IDTemporary number -29569

Timeline

Milestones

Study first posted2026-02-02actual
Last update posted2026-02-02actual
Study start2026-05-01estimated
Primary completion2027-12-31estimated
Study completion2028-07-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Atrial fibrillationObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age between 18 and 80 years.

2. Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.

3. Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).

4. Able and willing to provide written informed consent.

Exclusion criteria

1. Long-standing AF or marked left atrial enlargement (persistent AF duration > 5 years or left atrial anterior-posterior diameter > 50 mm).

2. AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery).

3. Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy).

4. Planned major non-AF-related surgery or interventional procedure within 3 months.

5. Other arrhythmias requiring chronic antiarrhythmic drug therapy.

6. Intracardiac thrombus or any contraindication to catheter ablation as judged by the investigator.

7. Active systemic infection at screening.

8. Contraindications to tirzepatide or GLP-1/GIP receptor agonists (e.g., prior serious hypersensitivity, personal or family history of medullary thyroid carcinoma or MEN2, history of clinically significant pancreatitis, severe gastrointestinal disease that may impair tolerance or absorption).

9. Poorly controlled type 1 diabetes, recent diabetic ketoacidosis, end-stage renal disease requiring dialysis, or severe hepatic dysfunction judged clinically significant.

10. Pregnancy, breastfeeding, or women of childbearing potential unwilling or unable to use adequate contraception during the study.

11. Participation in another interventional clinical study within 30 days prior to screening or planned participation during the study period.

12. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation, including inability to comply with study procedures or follow-up.

Endpoints (6)

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.

Coverage by outcome category

Cardiovascular outcomes
4
Patient-reported / QoL
1
Other (unclassified)
1

Cardiovascular outcomes

4 endpoints
Primary/protocol endpoint/low confidence

Atrial fibrillation burden at 3 months after catheter ablation

Time frame:3 months after catheter ablation (7-day ECG patch monitoring period)

descriptive, improvement

Secondary/protocol endpoint

Atrial fibrillation recurrence within 3 months after catheter ablation

Time frame:From the date of ablation to 3 months after ablation

Atrial-fibrillation composite

time to event, event

Secondary/protocol endpoint

Atrial fibrillation recurrence within 12 months after catheter ablation

Time frame:From the date of ablation to 12 months after ablation

Atrial-fibrillation composite

time to event, event

componentsAtrial-fibrillation composite

Secondary/protocol endpoint

Cardiovascular death or cardiovascular hospitalization within 12 months

Time frame:From the date of ablation to 12 months after ablation

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, All-cause hospitalization

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in atrial fibrillation-related quality of life (AFEQT score)

Time frame:Baseline and 3 months after ablation

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in left atrial structure by echocardiography at 3 months

Time frame:Baseline and 3 months after ablation

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.