Atrial Fibrillation (AF)OBESE-AFNCT07618741
Improving Outcomes After AF Ablation in Obese Patients
A study testing Cardiac Rehabilitation and Lifestyle Modification in people with Atrial Fibrillation (AF) and Obesity (Disorder), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Improving Outcomes After AF Ablation in Obese Patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Obesity (Disorder)
- What is being tested?
- Cardiac Rehabilitation and Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2021to May 2030
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Class I indication of catheter ablation of paroxysmal or persistent AF and will undergo catheter ablation at National Taiwan University Hospital.
Who cannot join
- Informed consent could not be obtained due to personal problem
- Unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular
- Current or scheduled enrollment in other conflicting studies, and
- Concomitant disease or other medical condition likely to result in death within 6 months
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, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Official title: Outcome Improvement in Obese Patients With Atrial Fibrillation After Catheter Ablation: Importance of Gut Microbiota Dysbiosis and Adipose Tissue Biology
Improving Outcomes After AF Ablation in Obese Patients
Read the detailed description
This is a prospective randomized clinical study designed to evaluate the roles of gut microbiota dysbiosis, adipose tissue biology, and post-ablation lifestyle intervention in patients with atrial fibrillation undergoing catheter ablation. Patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation at National Taiwan University Hospital will be enrolled after informed consent.
All participants will undergo standard-of-care catheter ablation and receive guideline-directed management for atrial fibrillation, including treatment of cardiovascular conditions, anticoagulation, and rate or rhythm control as clinically indicated. After the index ablation procedure, participants will be randomly assigned in a 1:1 ratio to either an intensive lifestyle modification program or usual care.
Participants assigned to the intensive lifestyle modification group will receive dietary counseling for weight reduction when indicated and an exercise-based cardiac rehabilitation program. The rehabilitation program will include supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise. Participants assigned to the usual care group will continue their usual lifestyle and receive standard post-ablation clinical follow-up.
The study will collect clinical characteristics, procedural data, rhythm follow-up data, biological samples, and imaging-based measurements. Gut microbiota dysbiosis will be assessed using stool specimens and high-throughput sequencing of the V3 and V4 hypervariable regions of 16S rRNA. Adipose tissue biology will be evaluated using computed tomography to quantify the amount and distribution of adipose tissue, including epicardial, paracardial, pericardial, visceral, and subcutaneous fat. Serum biomarkers related to inflammation and fibrosis, including hs-CRP, TNF-alpha, IL-1 beta, ST2, and galectin-3, will also be assessed.
Cardiac structural remodeling will be evaluated using cardiac computed tomography and echocardiography, including left atrial size, left ventricular mass, left ventricular ejection fraction, and parameters of left ventricular diastolic function. Electrophysiological remodeling of the left atrium will be assessed using three-dimensional voltage mapping during the ablation procedure, including the extent of scar and low-voltage zones.
Participants will undergo rhythm follow-up after catheter ablation using 12-lead electrocardiography, continuous patch electrocardiographic monitoring, and Holter monitoring as clinically indicated. The study will evaluate AF-free survival after the blanking period and will explore whether the post-ablation lifestyle intervention modifies ablation outcomes, body mass index, metabolic parameters, gut microbiota dysbiosis, adipose tissue biology, cardiac structural remodeling, and electrophysiological remodeling.
- Conditions
- Atrial Fibrillation (AF), Obesity (Disorder)
- Being tested
- Cardiac Rehabilitation and Lifestyle Modification, Usual Care
- Keywords
- Atrial fibrillation, Catheter ablation, Obesity, Gut microbiota dysbiosis, Epicardial adipose tissue, Cardiac rehabilitation, Lifestyle modification, Left atrial remodeling
- Medical subject headings
- Atrial Fibrillation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation and Lifestyle ModificationBehavioural
The intervention consists an exercise-based cardiac rehabilitation program after catheter ablation. The rehabilitation program includes supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise.
Usual CareBehavioural
Participants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation | Experimental | Participants assigned to this arm will receive an intensive lifestyle modification program after the index catheter ablation procedure. The program includes an exercise-based cardiac rehabilitation program with aerobic exercise and resistance or strength training, in addition to standard post-ablation care. Receives: Behavioral: Cardiac Rehabilitation and Lifestyle Modification |
| Usual Care | Active comparator | Participants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation-Free Survival After Catheter Ablation
Atrial fibrillation-free survival after the 3-month blanking period following the index catheter ablation procedure. Rhythm status will be assessed using 12-lead electrocardiography, 7-day continuous patch electrocardiographic monitoring at 6 months, and annual 24-hour Holter monitoring after the index ablation procedure.
Measured: From 3 months after catheter ablation through study follow-up, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start16 Sep 2021
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618741
- Sponsor's protocol ID
- 202006062RINC
- Acronym
- OBESE-AF
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Improvement in Obese Patients With Atrial Fibrillation After Catheter Ablation: Importance of Gut Microbiota Dysbiosis and Adipose Tissue Biology
- ClinicalTrials.gov ID
- NCT07618741
- Acronym / sponsor ID
- OBESE-AF / 202006062RINC
- Conditions
- Atrial Fibrillation (AF), Obesity (Disorder)
- Keywords
- Atrial fibrillation, Catheter ablation, Obesity, Gut microbiota dysbiosis, Epicardial adipose tissue, Cardiac rehabilitation, Lifestyle modification, Left atrial remodeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 1 Jun 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.
Improving Outcomes After AF Ablation in Obese Patients
Detailed description
This is a prospective randomized clinical study designed to evaluate the roles of gut microbiota dysbiosis, adipose tissue biology, and post-ablation lifestyle intervention in patients with atrial fibrillation undergoing catheter ablation. Patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation at National Taiwan University Hospital will be enrolled after informed consent.
All participants will undergo standard-of-care catheter ablation and receive guideline-directed management for atrial fibrillation, including treatment of cardiovascular conditions, anticoagulation, and rate or rhythm control as clinically indicated. After the index ablation procedure, participants will be randomly assigned in a 1:1 ratio to either an intensive lifestyle modification program or usual care.
Participants assigned to the intensive lifestyle modification group will receive dietary counseling for weight reduction when indicated and an exercise-based cardiac rehabilitation program. The rehabilitation program will include supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise. Participants assigned to the usual care group will continue their usual lifestyle and receive standard post-ablation clinical follow-up.
The study will collect clinical characteristics, procedural data, rhythm follow-up data, biological samples, and imaging-based measurements. Gut microbiota dysbiosis will be assessed using stool specimens and high-throughput sequencing of the V3 and V4 hypervariable regions of 16S rRNA. Adipose tissue biology will be evaluated using computed tomography to quantify the amount and distribution of adipose tissue, including epicardial, paracardial, pericardial, visceral, and subcutaneous fat. Serum biomarkers related to inflammation and fibrosis, including hs-CRP, TNF-alpha, IL-1 beta, ST2, and galectin-3, will also be assessed.
Cardiac structural remodeling will be evaluated using cardiac computed tomography and echocardiography, including left atrial size, left ventricular mass, left ventricular ejection fraction, and parameters of left ventricular diastolic function. Electrophysiological remodeling of the left atrium will be assessed using three-dimensional voltage mapping during the ablation procedure, including the extent of scar and low-voltage zones.
Participants will undergo rhythm follow-up after catheter ablation using 12-lead electrocardiography, continuous patch electrocardiographic monitoring, and Holter monitoring as clinically indicated. The study will evaluate AF-free survival after the blanking period and will explore whether the post-ablation lifestyle intervention modifies ablation outcomes, body mass index, metabolic parameters, gut microbiota dysbiosis, adipose tissue biology, cardiac structural remodeling, and electrophysiological remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation | Experimental | Behavioral: Cardiac Rehabilitation and Lifestyle ModificationParticipants assigned to this arm will receive an intensive lifestyle modification program after the index catheter ablation procedure. The program includes an exercise-based cardiac rehabilitation program with aerobic exercise and resistance or strength training, in addition to standard post-ablation care. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Class I indication of catheter ablation of paroxysmal or persistent AF and will undergo catheter ablation at National Taiwan University Hospital.
Key exclusion criteria (4 listed)
- Informed consent could not be obtained due to personal problem
- Unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular
- Current or scheduled enrollment in other conflicting studies, and
- Concomitant disease or other medical condition likely to result in death within 6 months
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 |
|---|---|---|
| Cardiac Rehabilitation and Lifestyle ModificationThe intervention consists an exercise-based cardiac rehabilitation program after catheter ablation. The rehabilitation program includes supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise. | Behavioural | Cardiac rehabilitation |
| Usual CareParticipants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure. | Behavioural | Usual Care |
Primary outcome
Atrial Fibrillation-Free Survival After Catheter Ablation
Time frame: From 3 months after catheter ablation through study follow-up, up to 36 months
Atrial fibrillation-free survival after the 3-month blanking period following the index catheter ablation procedure. Rhythm status will be assessed using 12-lead electrocardiography, 7-day continuous patch electrocardiographic monitoring at 6 months, and annual 24-hour Holter monitoring after the index ablation procedure.
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 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Cardiac Rehabilitation and Lifestyle Modification in people with Atrial Fibrillation (AF) and Obesity (Disorder), 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 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 Yen Bin, Liu Associate Professor of Medicine, MD, PhD (+886-0972651035, yenbin@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-Free Survival After Catheter Ablation (time frame: From 3 months after catheter ablation through study follow-up, up to 36 months). 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 1 Jun 2026.