Bariatric Atrial Restoration of Sinus Rhythm (BAROS)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    534
  • sponsor
    Stanford University
Updated on 3 March 2022
diabetes
hypertension
type 2 diabetes mellitus
fibrillation
cardiomyopathy
fatty liver
apnea
steatosis
antihypertensive drugs
catheter ablation
antiarrhythmic drug
antihypertensive agents
arthropathy
bariatric surgery
paroxysmal atrial fibrillation
hyperlipidemia

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

Details
Condition Atrial Fibrillation, Morbid Obesity
Treatment Bariatric Surgery, Atrial Fibrillation (AF) Catheter Ablation
Clinical Study IdentifierNCT04050969
SponsorStanford University
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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

BMI > 65 kg/m2
Contraindication to bariatric surgery or AF ablation
Contraindication to therapeutic anticoagulation
Sustained AF lasting more than 3 years
Prior bariatric surgery
Left atrial diameter of greater than or equal to 60 mm or LA volume greater than or equal to 60 ml/m2
Prior AF catheter ablation
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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