Bariatric Atrial Restoration of Sinus Rhythm

Trial ID or NCT#

NCT04050969

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Investigator(s)

Paul J. Wang, MD
Paul J. Wang, MD
Cardiac electrophysiologist
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
Bariatric surgeon, General surgeon, Minimally invasive surgeon, Gastrointestinal surgeon
Associate Professor of Surgery (General Surgery)

Contact us to find out if this trial is right for you.

Contact

Linda K Ottoboni, PhD
650-498-5914

View on ClinicalTrials.gov