Bariatric Atrial Restoration of Sinus Rhythm

NCT ID: NCT04050969

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-07-01

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

Conditions

Atrial Fibrillation; Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Atrial Fibrillation (AF) Catheter Ablation

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Bariatric surgery

Intervention Type: PROCEDURE

Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.

Atrial Fibrillation (AF) Catheter Ablation

Intervention Type: PROCEDURE

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.

Interventions

Bariatric surgery

Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Paul Wang

Director, Stanford Electrophysiology and Arrhythmia Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Director Stanford Electrophysiology and Arrhythmia Service, Stanford University

Dan E Azagury, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery

Locations

Stanford Health Care

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29025560 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24685669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24240932 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29912366 (View on PubMed)

Other Identifiers

ID # 49225

Identifier Type: -

Identifier Source: org_study_id