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Bariatric Atrial Restoration of Sinus Rhythm (BAROS)

Primary Purpose

Atrial Fibrillation, Morbid Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bariatric surgery
Atrial Fibrillation (AF) Catheter Ablation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atrial Fibrillation (AF) Catheter Ablation-Group A

Bariatric surgery prior to AF Catheter Ablation-Group B

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
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.
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.
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.
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.

Full Information

First Posted
August 7, 2019
Last Updated
October 17, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04050969
Brief Title
Bariatric Atrial Restoration of Sinus Rhythm
Acronym
BAROS
Official Title
Bariatric Atrial Restoration of Sinus Rhythm
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficult enrollment
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will undergo screening and eligibility to make sure they meet all criteria for the trial. If patients meet all defined criteria, they will undergo informed consent and will be randomized with equal allocation to the catheter ablation only and bariatric surgery plus AF catheter ablation arms. Randomization will be stratified by site and type of AF (paroxysmal or persistent) using permuted blocks to limit effects of clinician variation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrial Fibrillation (AF) Catheter Ablation-Group A
Arm Type
Active Comparator
Arm 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.
Arm Title
Bariatric surgery prior to AF Catheter Ablation-Group B
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
Intervention Type
Procedure
Intervention Name(s)
Atrial Fibrillation (AF) Catheter Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first recurrence of AF following a 3-month blanking period after the ablation.
Description
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 Frame
Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
Secondary Outcome Measure Information:
Title
Change in AF Burden off anti-arrhythmic agents monitor
Description
The percentage of time in AF burden on the cardiac monitor will be calculated
Time Frame
Baseline (Initial), 3 months)
Title
Change in AF Burden off anti-arrhythmic agents monitor
Description
The percentage of time in AF burden on the cardiac monitor will be calculated
Time Frame
Baseline (Initial), 6 months)
Title
Change in AF Burden off anti-arrhythmic agents monitor
Description
The percentage of time in AF burden on the cardiac monitor will be calculated
Time Frame
Baseline (Initial), 12 months)
Title
Change from Baseline in AF Quality of Life Score
Description
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.
Time Frame
Baseline (Initial), 6 months
Title
Change from Baseline in AF Quality of Life Score
Description
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.
Time Frame
Baseline (Initial), 12 months
Title
Change from Baseline in AF symptom severity
Description
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.
Time Frame
Baseline (Initial), 6 months
Title
Change from Baseline in AF symptom severity
Description
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.
Time Frame
Baseline (Initial), 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Wang, MD
Organizational Affiliation
Director Stanford Electrophysiology and Arrhythmia Service, Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan E Azagury, MD
Organizational Affiliation
Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29025560
Citation
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.
Results Reference
background
PubMed Identifier
24685669
Citation
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.
Results Reference
background
PubMed Identifier
24240932
Citation
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.
Results Reference
background
PubMed Identifier
29912366
Citation
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.
Results Reference
background

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Bariatric Atrial Restoration of Sinus Rhythm

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