Atrial Fibrillation AblationTREAT-AFNCT07382024
Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
A study testing Tirzepatide in people with Atrial Fibrillation Ablation and Persistent Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation Ablation, Persistent Atrial Fibrillation, Obesity & Overweight
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jun 2026to 31 Jul 2028
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
- Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).
- Able and willing to provide written informed consent.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital Cardiovascular Center
Taipei, 100
About this study
Official title: Tirzepatide to Reduce Recurrence and Burden After Catheter Ablation of Atrial Fibrillation: A Prospective Randomized Trial
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:
Read more
- 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?
- Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone?
- 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.
Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.
Read the detailed description
Atrial fibrillation (AF) is one of the most common sustained arrhythmias and is associated with increased risks of stroke, heart failure, cognitive decline, and mortality, creating a substantial burden for patients and healthcare systems. Catheter ablation has become an important rhythm-control strategy that can restore sinus rhythm and improve quality of life in patients with AF. However, 30-50% of patients still experience recurrent atrial tachyarrhythmias after ablation, and higher AF burden has been linked to worse clinical outcomes, making AF burden a clinically relevant endpoint beyond a simple yes/no definition of recurrence.
Obesity and metabolic dysfunction are major upstream drivers of AF, promoting atrial structural and electrical remodeling through hemodynamic load, epicardial fat accumulation, systemic inflammation, and neurohormonal activation. Intensive lifestyle and risk-factor management programs can reduce AF burden and improve ablation outcomes, but such interventions are often difficult to implement and sustain in routine practice. Pharmacologic therapies that induce substantial and durable weight loss and improve cardiometabolic risk may therefore offer a practical strategy to lower AF burden after ablation in overweight or obese patients.
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that has produced large and sustained weight loss and broad cardiometabolic benefits in patients with obesity and type 2 diabetes, including improvements in glycemic control, blood pressure, and lipid profiles. In high-risk cardiometabolic populations, tirzepatide has also been associated with reductions in heart failure events and markers of congestion, suggesting favorable effects on cardiac loading conditions and structural remodeling. These data provide a strong rationale to test whether tirzepatide-induced weight loss and metabolic improvement can translate into reduced AF burden after catheter ablation.
The TREAT-AF trial is an investigator-initiated, multi-center, open-label, endpoint-blinded randomized controlled trial in adults with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants are randomized 1:1 to receive peri-procedural tirzepatide in addition to standard care or standard care alone. Tirzepatide is started approximately 4 weeks before the ablation procedure and continued for 3 months afterward, aligning pharmacologic weight loss and metabolic optimization with the period of atrial healing and electrical remodeling after ablation. AF burden at 3 months is assessed by 7-day single-lead ECG patches and adjudicated by a blinded endpoint assessment committee. Secondary assessments include AF recurrence, echocardiographic measures of left atrial structure, metabolic parameters, quality of life using the AFEQT questionnaire, and cardiovascular events through 12 months of follow-up.
- Being tested
- Tirzepatide, Standard Care (in control arm)
- Keywords
- Atrial fibrillation, Catheter ablation, Tirzepatide, Overweight and obesity, AF burden, Recurrence, Quality of life
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care（Intervention: Other - standard care / no tirzepatide） | Active comparator | Not described Receives: Other: Standard Care (in control arm) |
| Tirzepatide + Standard Care（Intervention: Drug - tirzepatide） | Active comparator | Not described Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after catheter ablation (7-day ECG patch monitoring period)
Secondary outcomes (5)
Atrial fibrillation recurrence within 3 months after catheter ablation
AF recurrence is defined as the first documented episode of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, detected by ECG monitoring or clinically indicated ECG during the first 3 months after ablation. Episodes occurring within a standard blanking period, if applicable, will be handled according to the study protocol.
Measured: From the date of ablation to 3 months after ablation
Change in left atrial structure by echocardiography at 3 months
Change from baseline to 3 months in echocardiographic measures of left atrial structure (left atrial volume indices), assessed by transthoracic echocardiography according to standard guidelines.
Measured: Baseline and 3 months after ablation
Change in atrial fibrillation-related quality of life questionnaire
Change from baseline to 3 months in health-related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, using a validated Chinese version for Chinese-speaking participants. Higher scores indicate better quality of life.
Measured: Baseline and 3 months after ablation
Atrial fibrillation recurrence within 12 months after catheter ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, detected by ECG or rhythm monitoring during 12 months of follow-up after ablation.
Measured: From the date of ablation to 12 months after ablation
Cardiovascular death or cardiovascular hospitalization within 12 months
Composite of cardiovascular death or hospitalization for cardiovascular causes (e.g., heart failure, acute coronary syndrome, stroke, or other predefined cardiovascular events), defined according to consensus cardiovascular endpoint definitions and adjudicated by the Endpoint Assessment Committee.
Measured: From the date of ablation to 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start16 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation AblationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382024
- Sponsor's protocol ID
- 202604149MIND
- Acronym
- TREAT-AF
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planned at this time because the protocol and consent forms were not specifically designed for external data sharing. Future sharing may be reconsidered if appropriate regulatory approvals, institutional policies, and participant consent can be ensured.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirzepatide to Reduce Recurrence and Burden After Catheter Ablation of Atrial Fibrillation: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07382024
- Acronym / sponsor ID
- TREAT-AF / 202604149MIND
- Keywords
- Atrial fibrillation, Catheter ablation, Tirzepatide, Overweight and obesity, AF burden, Recurrence, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Feb 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.
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:
- 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?
- Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone?
- 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.
Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.
Detailed description
Atrial fibrillation (AF) is one of the most common sustained arrhythmias and is associated with increased risks of stroke, heart failure, cognitive decline, and mortality, creating a substantial burden for patients and healthcare systems. Catheter ablation has become an important rhythm-control strategy that can restore sinus rhythm and improve quality of life in patients with AF. However, 30-50% of patients still experience recurrent atrial tachyarrhythmias after ablation, and higher AF burden has been linked to worse clinical outcomes, making AF burden a clinically relevant endpoint beyond a simple yes/no definition of recurrence.
Obesity and metabolic dysfunction are major upstream drivers of AF, promoting atrial structural and electrical remodeling through hemodynamic load, epicardial fat accumulation, systemic inflammation, and neurohormonal activation. Intensive lifestyle and risk-factor management programs can reduce AF burden and improve ablation outcomes, but such interventions are often difficult to implement and sustain in routine practice. Pharmacologic therapies that induce substantial and durable weight loss and improve cardiometabolic risk may therefore offer a practical strategy to lower AF burden after ablation in overweight or obese patients.
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that has produced large and sustained weight loss and broad cardiometabolic benefits in patients with obesity and type 2 diabetes, including improvements in glycemic control, blood pressure, and lipid profiles. In high-risk cardiometabolic populations, tirzepatide has also been associated with reductions in heart failure events and markers of congestion, suggesting favorable effects on cardiac loading conditions and structural remodeling. These data provide a strong rationale to test whether tirzepatide-induced weight loss and metabolic improvement can translate into reduced AF burden after catheter ablation.
The TREAT-AF trial is an investigator-initiated, multi-center, open-label, endpoint-blinded randomized controlled trial in adults with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants are randomized 1:1 to receive peri-procedural tirzepatide in addition to standard care or standard care alone. Tirzepatide is started approximately 4 weeks before the ablation procedure and continued for 3 months afterward, aligning pharmacologic weight loss and metabolic optimization with the period of atrial healing and electrical remodeling after ablation. AF burden at 3 months is assessed by 7-day single-lead ECG patches and adjudicated by a blinded endpoint assessment committee. Secondary assessments include AF recurrence, echocardiographic measures of left atrial structure, metabolic parameters, quality of life using the AFEQT questionnaire, and cardiovascular events through 12 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years.
- Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
- Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).
- Able and willing to provide written informed consent.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| TirzepatideSubcutaneous 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. | Drug | Tirzepatide + Standard Care（Intervention: Drug - tirzepatide） |
| Standard Care (in control arm)Standard peri-procedural and post-ablation care for persistent atrial fibrillation without tirzepatide or other study-specific metabolic pharmacotherapy. | Other | Standard Care（Intervention: Other - standard care / no tirzepatide） |
Primary outcome
Atrial fibrillation burden at 3 months after catheter ablation
Time frame: 3 months after catheter ablation (7-day ECG patch monitoring period)
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.
5 secondary outcomes
Atrial fibrillation recurrence within 3 months after catheter ablation
Time frame: From the date of ablation to 3 months after ablation
Change in left atrial structure by echocardiography at 3 months
Time frame: Baseline and 3 months after ablation
Change in atrial fibrillation-related quality of life questionnaire
Time frame: Baseline and 3 months after ablation
Atrial fibrillation recurrence within 12 months after catheter ablation
Time frame: From the date of ablation to 12 months after ablation
Cardiovascular death or cardiovascular hospitalization within 12 months
Time frame: From the date of ablation to 12 months after ablation
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 12 Jun 2026.
- Individual participant dataSharing planned: No. IPD sharing is not planned at this time because the protocol and consent forms were not specifically designed for external data sharing. Future sharing may be reconsidered if appropriate regulatory approvals, institutional policies, and participant consent can be ensured.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tirzepatide in people with Atrial Fibrillation Ablation and Persistent Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 12 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Ting-Tse Lin, MD. Ph.D. (+886-972653620, ttlin111@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden at 3 months after catheter ablation (time frame: 3 months after catheter ablation (7-day ECG patch monitoring period)). 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 12 Jun 2026.