Bariatric Atrial Restoration of Sinus Rhythm (BAROS)

Stanford University

Status: Terminated

Conditions: Atrial Fibrillation; Morbid Obesity

Treatments: Procedure: Bariatric surgery; Procedure: Atrial Fibrillation (AF) Catheter Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04050969

ID # 49225

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Atrial Fibrillation (AF) Catheter Ablation-Group A

Active Comparator group

Description:

Participants will undergo catheter ablation using either radiofrequency or cryo-ablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extra-pulmonary sites at the physician's discretion.

Treatment:

Procedure: Atrial Fibrillation (AF) Catheter Ablation

Bariatric surgery prior to AF Catheter Ablation-Group B

Experimental group

Description:

Participants will undergo either a Roux-en-Y gastric bypass or a laparoscopic sleeve gastrectomy. The choice of the procedure will be based on numerous factors including current practice, the surgeon's and participant's choice, BMI, and the presence of certain comorbidities and their severity such as GERD, kidney stones, and past surgical history. Participants will undergo standard preoperative evaluation including dietary consultation and psychological evaluation during the eligibility process. After bariatric surgery, in addition to routine post-surgical management, patients will follow up with cardiologist prior to AF catheter ablation.

Treatment:

Procedure: Atrial Fibrillation (AF) Catheter Ablation

Procedure: Bariatric surgery