Status:
TERMINATED
Bariatric Atrial Restoration of Sinus Rhythm
Lead Sponsor:
Stanford University
Conditions:
Atrial Fibrillation
Morbid Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
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 fibri...
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04050969
Start Date
October 1 2020
End Date
July 1 2022
Last Update
October 19 2022
Active Locations (1)
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1
Stanford Health Care
Stanford, California, United States, 94305