Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

NCT07382024 | Not Yet Recruiting DMC

• 1 other identifier: Temporary number -29569
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population. The main questions it aims to answer are:

1. 1.Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring?
2. 2.Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone?
3. 3.Does tirzepatide reduce AF recurrence and cardiovascular events during 12 months of follow-up? Researchers will conduct a multi-center, open-label, endpoint-blinded, randomized controlled trial in adults aged 18-80 years with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants will be randomized 1:1 to receive either tirzepatide plus standard peri-procedural and post-ablation care or standard care alone.

Conditions

Atrial Fibrillation Ablation; Persistent Atrial Fibrillation; Obesity & Overweight

Keywords

Atrial fibrillation; Catheter ablation; Tirzepatide; Overweight and obesity; AF burden; Recurrence; Quality of life

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden at 3 months after catheter ablation

  AF burden is defined as the proportion of time an individual is in any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) during a 7-day monitoring period, assessed using continuous single-lead ECG patch recordings. AF burden will be adjudicated by a blinded Endpoint Assessment Committee based on de-identified ECG data.

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

Secondary Outcomes (5)

• Atrial fibrillation recurrence within 3 months after catheter ablation

  From the date of ablation to 3 months after ablation

• Change in left atrial structure by echocardiography at 3 months

  Baseline and 3 months after ablation

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

  Baseline and 3 months after ablation

• Atrial fibrillation recurrence within 12 months after catheter ablation

  From the date of ablation to 12 months after ablation

• Cardiovascular death or cardiovascular hospitalization within 12 months

  From the date of ablation to 12 months after ablation

Study Arms (2)

Standard Care（Intervention: Other - standard care / no tirzepatide）

ACTIVE COMPARATOR

Other: Standard Care (in control arm)

Tirzepatide + Standard Care（Intervention: Drug - tirzepatide）

ACTIVE COMPARATOR

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Subcutaneous tirzepatide 2.5 mg once weekly, initiated approximately 4 weeks before the scheduled de novo catheter ablation and continued for 3 months after the procedure (total treatment duration about 4 months), in addition to standard peri-procedural and post-ablation care.

Tirzepatide + Standard Care（Intervention: Drug - tirzepatide）

Standard Care (in control arm) OTHER

Standard peri-procedural and post-ablation care for persistent atrial fibrillation without tirzepatide or other study-specific metabolic pharmacotherapy.

Standard Care（Intervention: Other - standard care / no tirzepatide）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
• Body mass index (BMI) ≥ 25 kg/m² at screening.
• Able and willing to provide written informed consent.

You may not qualify if:

• Long-standing AF or marked left atrial enlargement (persistent AF duration \> 5 years or left atrial anterior-posterior diameter \> 50 mm).
• AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery).
• Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy).
• Planned major non-AF-related surgery or interventional procedure within 3 months.
• Other arrhythmias requiring chronic antiarrhythmic drug therapy.
• Intracardiac thrombus or any contraindication to catheter ablation as judged by the investigator.
• Active systemic infection at screening.
• 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).
• Poorly controlled type 1 diabetes, recent diabetic ketoacidosis, end-stage renal disease requiring dialysis, or severe hepatic dysfunction judged clinically significant.
• Pregnancy, breastfeeding, or women of childbearing potential unwilling or unable to use adequate contraception during the study.
• Participation in another interventional clinical study within 30 days prior to screening or planned participation during the study period.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Cardiovascular Center

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Obesity; Overweight; Recurrence

Interventions

Tirzepatide; Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ting-Tse Lin, MD. Ph.D.

CONTACT

+886-972653620; ttlin111@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although participants and treating investigators are not masked to treatment assignment (open-label design), the independent Endpoint Assessment Committee is fully blinded to group allocation when adjudicating the primary endpoint of atrial fibrillation burden and other adjudicated outcomes, using de-identified ECG and clinical data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: This is a multi-center, open-label, parallel-group randomized controlled trial. Eligible patients with persistent atrial fibrillation scheduled for de novo catheter ablation are randomized in a 1:1 ratio to receive tirzepatide plus standard peri-procedural and post-ablation care or standard care alone. Participants remain in their originally assigned treatment group for all analyses according to the intention-to-treat principle.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)