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Improving Outcomes After AF Ablation in Obese Patients

ConditionsAtrial Fibrillation (AF)Obesity (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

Improving Outcomes After AF Ablation in Obese Patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Cardiac rehabilitationExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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