Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients (OSA-AFIB)

Effects of Positive Airway Pressure on Atrial Fibrillation Recurrence Risk After Catheter Ablation in Patients With Atrial Fibrillation and Obstructive Sleep Apnea-A Pilot Randomized Controlled Trial

With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation; Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Cardiac Ablation for Atrial Fibrillation

Detailed Description

Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for short periods during sleep, is a common condition in patients with atrial fibrillation. Studies have shown that up to 75% of atrial fibrillation patients undergoing catheter ablation procedure have obstructive sleep apnea. Obstructive sleep apnea increases the risk of atrial fibrillation recurrence after successful catheter ablation by 40%. However, whether treatment of obstructive sleep apnea with positive airway pressure (PAP, the current most effective treatment for obstructive sleep apnea that uses a machine to help breathe more easily) reduces the risk of atrial fibrillation recurrence is not fully understood. The purpose of this study, therefore, is to examine whether positive airway pressure therapy reduces atrial fibrillation recurrence after catheter ablation in patients with obstructive sleep apnea and atrial fibrillation.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Sleep Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women 18 years or older
2. First-time catheter ablation for atrial fibrillation
3. Moderate-to-severe obstructive sleep apnea diagnosed with a sleep study (apnea-hypopnea index ≥ 15)

Exclusion Criteria:

1. Current or prior use of positive airway pressure for obstructive sleep apnea
2. Any household member with current/past positive airway pressure use
3. Did not meet minimal adherence to positive airway pressure treatment (≥ 4 hours/night and ≥ 70% of time in 2 weeks)
4. History of motor vehicle or occupational accident related to excessive sleepiness
5. Severe nocturnal desaturation documented on sleep study as >10% of total sleep time with oxygen saturation of < 75%
6. Any condition determined by physicians that constrains the use of positive airway pressure such as anatomically fixed nasal obstruction, neurological impairment, and significant claustrophobia.
7. Congestive heart failure (New York Heart Association IV)
8. Severe valvular disease
9. Planned coronary revascularization procedure in the next 6 months
10. Severe pulmonary disease
11. Participation in another treatment intervention trial that might influence results of this trial
12. Ablation procedure scheduled in the next 8 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Positive Airway Pressure; Active positive airway pressure for treatment of Obstructive Sleep Apnea	Procedure: Cardiac Ablation for Atrial Fibrillation; Ablation of arrhythmia focus in the heart for atrial fibrillation
Sham Comparator: Sham Positive Airway Pressure; Sham positive airway pressure for treatment of Obstructive Sleep Apnea	Procedure: Cardiac Ablation for Atrial Fibrillation; Ablation of arrhythmia focus in the heart for atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation recurrence	Risk of Atrial Fibrillation recurrence	6 months after ablation

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease Attributes; Arrhythmias, Cardiac; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 41798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes