Clinical trial NCT04050969: Bariatric Atrial Restoration of Sinus Rhythm
Official title: Bariatric Atrial Restoration of Sinus Rhythm
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Morbid Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Time to first recurrence of AF following a 3-month blanking period after the ablation.
timeFrame: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
Secondary outcomes:
measure: Change in AF Burden off anti-arrhythmic agents monitor
timeFrame: Baseline (Initial), 3 months)
measure: Change in AF Burden off anti-arrhythmic agents monitor
timeFrame: Baseline (Initial), 6 months)
measure: Change in AF Burden off anti-arrhythmic agents monitor
timeFrame: Baseline (Initial), 12 months)
measure: Change from Baseline in AF Quality of Life Score
timeFrame: Baseline (Initial), 6 months
measure: Change from Baseline in AF Quality of Life Score
timeFrame: Baseline (Initial), 12 months
measure: Change from Baseline in AF symptom severity
timeFrame: Baseline (Initial), 6 months
measure: Change from Baseline in AF symptom severity
timeFrame: Baseline (Initial), 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Director Stanford Electrophysiology and Arrhythmia Service, Stanford University
name: Paul J Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery
name: Dan E Azagury, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.