Bariatric Atrial Restoration of Sinus Rhythm

Atrial Fibrillation Clinical Trial

— BAROS  

Official title:

Bariatric Atrial Restoration of Sinus Rhythm

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04050969
• Other study ID #: ID # 49225
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
• 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.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. Erratum in: J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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