Bariatric Atrial Restoration of Sinus Rhythm (BAROS)
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- STATUS
- Recruiting
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- End date
- Dec 1, 2023
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- participants needed
- 534
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- sponsor
- Stanford University
Summary
The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.
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 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
Details
| Condition | Atrial Fibrillation, Morbid Obesity |
|---|---|
| Treatment | Bariatric Surgery, Atrial Fibrillation (AF) Catheter Ablation |
| Clinical Study Identifier | NCT04050969 |
| Sponsor | Stanford University |
| Last Modified on | 3 March 2022 |
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