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Bariatric Atrial Restoration of Sinus Rhythm

NCT04050969 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-10-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Bariatric surgery

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

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.

Sponsors & Collaborators

Principal Investigators

  • Paul J Wang, MD · Director Stanford Electrophysiology and Arrhythmia Service, Stanford University

  • Dan E Azagury, MD · Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050969 on ClinicalTrials.gov