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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
Participants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion.
Stanford Health Care
Stanford, California, United States
Time to first recurrence of AF following a 3-month blanking period after the ablation.
The primary outcome measure will be time to first recurrence of any atrial arrhythmia including AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds and occurring more than 3 months after AF ablation, without the use of antiarrhythmic medications. An episode of AF or atrial tachycardia will be considered part of the primary outcome analysis if it lasts longer than 30 seconds and is documented by any form of electrocardiographic monitoring, regardless of symptoms. A repeat catheter ablation procedure at any time will constitute a recurrence for the outcome analysis.
Time frame: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Time frame: Baseline (Initial), 3 months)
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Time frame: Baseline (Initial), 6 months)
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Time frame: Baseline (Initial), 12 months)
Change from Baseline in AF Quality of Life Score
Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.
Time frame: Baseline (Initial), 6 months
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Change from Baseline in AF Quality of Life Score
Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.
Time frame: Baseline (Initial), 12 months
Change from Baseline in AF symptom severity
AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Time frame: Baseline (Initial), 6 months
Change from Baseline in AF symptom severity
AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Time frame: Baseline (Initial), 12 months