Bariatric Atrial Restoration of Sinus Rhythm

Not Recruiting

Trial ID: NCT04050969


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.

Official Title

Bariatric Atrial Restoration of Sinus Rhythm

Stanford Investigator(s)

Paul  J. Wang, MD
Paul J. Wang, MD

John R. and Ai Giak L. Singleton Director, Professor of Medicine (Cardiovascular Medicine) and, by courtesy, of Bioengineering

Dan E. Azagury, MD, FACS
Dan E. Azagury, MD, FACS

Associate Professor of Surgery (General Surgery)


Inclusion Criteria:

   - Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic

   - 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

      - 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

      - 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


procedure: Bariatric surgery

procedure: Atrial Fibrillation (AF) Catheter Ablation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda K Ottoboni, PhD