Bariatric Atrial Restoration of Sinus Rhythm
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Fibrillation
- Morbid Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will undergo screening and eligibility to make sure they meet all criteria for the trial. If patients meet all defined criteria, they will undergo informed consent and will be randomized with equal allocation to the catheter ablation only and bariatric surgery plus AF catheter ablation arms. Randomization will be stratified by site and type of AF (paroxysmal or persistent) using permuted blocks to limit effects of clinician variation.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obes...
This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obesity. Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits Group A will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in Group B will be baseline, clinical visit prior AF ablation, and at 3, 6, and 12 months post AF ablation. At each post ablation visit the following data will be collected: AT/AF recurrence determined by ambulatory monitoring, clinic visit, or hospitalization; Physical Exam (weight, height, vitals); 12 lead ECG; Medication Regimen; AF Symptom Severity Scale (AFSS); Quality of Life (AFEQT); Laboratory Testing; and Adverse Events
Tracking Information
- NCT #
- NCT04050969
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paul J Wang, MD Director Stanford Electrophysiology and Arrhythmia Service, Stanford University Principal Investigator: Dan E Azagury, MD Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery