Bariatric Atrial Restoration of Sinus Rhythm (BAROS)

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Morbid Obesity
• Intervention / Treatment: Procedure: Atrial Fibrillation (AF) Catheter Ablation; Procedure: Bariatric surgery

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 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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atrial Fibrillation (AF) Catheter Ablation-Group A; 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.	Procedure: Atrial Fibrillation (AF) Catheter Ablation; Participants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion.
Experimental: Bariatric surgery prior to AF Catheter Ablation-Group B; 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.	Procedure: Atrial Fibrillation (AF) Catheter Ablation; Participants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion.; Procedure: Bariatric surgery; Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first recurrence of AF following a 3-month blanking period after the ablation.	The primary outcome measure will be time to first recurrence of any atrial arrhythmia including AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds and occurring more than 3 months after AF ablation, without the use of antiarrhythmic medications. An episode of AF or atrial tachycardia will be considered part of the primary outcome analysis if it lasts longer than 30 seconds and is documented by any form of electrocardiographic monitoring, regardless of symptoms. A repeat catheter ablation procedure at any time will constitute a recurrence for the outcome analysis.	Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in AF symptom severity	AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.	Baseline (Initial), 6 months
Change in AF Burden off anti-arrhythmic agents monitor	The percentage of time in AF burden on the cardiac monitor will be calculated	Baseline (Initial), 3 months)
Change in AF Burden off anti-arrhythmic agents monitor	The percentage of time in AF burden on the cardiac monitor will be calculated	Baseline (Initial), 6 months)
Change in AF Burden off anti-arrhythmic agents monitor	The percentage of time in AF burden on the cardiac monitor will be calculated	Baseline (Initial), 12 months)
Change from Baseline in AF Quality of Life Score	Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.	Baseline (Initial), 6 months
Change from Baseline in AF Quality of Life Score	Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.	Baseline (Initial), 12 months
Change from Baseline in AF symptom severity	AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.	Baseline (Initial), 12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Paul J Wang, MD, Director Stanford Electrophysiology and Arrhythmia Service, Stanford University; Principal Investigator: Dan E Azagury, MD, Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery

Publications and helpful links

General Publications

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7.
• Lavie CJ, Pandey A, Lau DH, Alpert MA, Sanders P. Obesity and Atrial Fibrillation Prevalence, Pathogenesis, and Prognosis: Effects of Weight Loss and Exercise. J Am Coll Cardiol. 2017 Oct 17;70(16):2022-2035. doi: 10.1016/j.jacc.2017.09.002.
• Abed HS, Wittert GA, Leong DP, Shirazi MG, Bahrami B, Middeldorp ME, Lorimer MF, Lau DH, Antic NA, Brooks AG, Abhayaratna WP, Kalman JM, Sanders P. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013 Nov 20;310(19):2050-60. doi: 10.1001/jama.2013.280521.
• Middeldorp ME, Pathak RK, Meredith M, Mehta AB, Elliott AD, Mahajan R, Twomey D, Gallagher C, Hendriks JML, Linz D, McEvoy RD, Abhayaratna WP, Kalman JM, Lau DH, Sanders P. PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study. Europace. 2018 Dec 1;20(12):1929-1935. doi: 10.1093/europace/euy117.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Arrhythmias, Cardiac; Obesity; Atrial Fibrillation; Obesity, Morbid
• Other Study ID Numbers: ID # 49225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No