Improving Outcomes After AF Ablation in Obese Patients

NCT07618741 | Recruiting

• 1 other identifier: 202006062RINC
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

Improving Outcomes After AF Ablation in Obese Patients

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From 3 months after catheter ablation through study follow-up, up to 36 months

Study Arms (2)

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.

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.

Behavioral: Usual Care

Interventions

Cardiac Rehabilitation and Lifestyle Modification BEHAVIORAL

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.

Cardiac rehabilitation

Usual Care BEHAVIORAL

Participants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure.

Usual Care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Class I indication of catheter ablation of paroxysmal or persistent AF and will undergo catheter ablation at National Taiwan University Hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Obesity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Yen Bin, Liu Associate Professor of Medicine, MD, PhD

CONTACT

+886-0972651035; yenbin@ntu.edu.tw

Chun Kai, Chen Visiting staff, MD

CONTACT

+886-0921915778; neochen@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: September 16, 2021
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

TW (1)