Atrial Fibrillation, Morbid Obesity
Conditions
Brief 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.
Detailed 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
Interventions
PROCEDUREBariatric surgery
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
PROCEDUREAtrial Fibrillation (AF) Catheter Ablation
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic agent * EF \> 40% * BMI \> 40 or BMI \> 35 and at least one of the following co-morbidities: * Type 2 Diabetes Mellitus (by American Diabetes Association diagnostic criteria). * Systolic blood pressure of 130 mmHg and/or diastolic blood pressure 80 mmHg or higher despite medical treatment with maximal doses of three antihypertensive medications). * Refractory hyperlipidemia (acceptable levels of lipids unachievable with diet and maximum doses of lipid lowering medications). * Obesity-induced cardiomyopathy. * Clinically significant obstructive sleep apnea. * Obesity-related hypoventilation. * Pseudotumor cerebri (documented idiopathic intracerebral hypertension). * Severe arthropathy of spine and/or weight-bearing joints (when obesity prohibits appropriate surgical management of joint dysfunction treatable but for the obesity). * Hepatic steatosis without evidence of active inflammation. * Hypertriglyceridemia * Polycystic Ovary Syndrome (PCOS) * Asthma * Coronary Artery Disease (CAD)
Exclusion criteria
* Prior bariatric surgery * Prior AF catheter ablation * BMI \> 65 kg/m2 * Contraindication to bariatric surgery or AF ablation * Contraindication to therapeutic anticoagulation * Sustained AF lasting more than 3 years * Left atrial diameter of greater than or equal to 60 mm or LA volume greater than or equal to 60 ml/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrence of AF following a 3-month blanking period after the ablation. | Time to first recurrence of AF following a 3-month blanking period after the AF Catheter 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AF Burden off anti-arrhythmic agents monitor | Baseline (Initial), 3 months) | The percentage of time in AF burden on the cardiac monitor will be calculated |
| Change from Baseline in AF Quality of Life Score | Baseline (Initial), 6 months | 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. |
| Change from Baseline in AF symptom severity | Baseline (Initial), 6 months | 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. |
Countries
United States
Outcome results
None listed