Trial Search Results

Bariatric Atrial Restoration of Sinus Rhythm

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Procedure: Bariatric surgery
  • Procedure: Atrial Fibrillation (AF) Catheter Ablation

Phase:

N/A

Eligibility


Inclusion Criteria:

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

   - EF > 40%

   - BMI > 40 or BMI > 35 and at least two 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.

Exclusion Criteria:

   - Prior bariatric surgery or 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

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda K Ottoboni, PhD
650-498-5914
Not Recruiting