Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Procedure: Cardiac Ablation for Atrial Fibrillation
    • Ablation of arrhythmia focus in the heart for atrial fibrillation

Arms, Groups and Cohorts

  • Active Comparator: Active Positive Airway Pressure
    • Active positive airway pressure for treatment of Obstructive Sleep Apnea
  • Sham Comparator: Sham Positive Airway Pressure
    • Sham positive airway pressure for treatment of Obstructive Sleep Apnea

Clinical Trial Outcome Measures

Primary Measures

  • Atrial Fibrillation recurrence
    • Time Frame: 6 months after ablation
    • Risk of Atrial Fibrillation recurrence

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Clete A. Kushida, Professor – Stanford University
  • Overall Official(s)
    • Clete A Kushida, MD, PhD, Principal Investigator, Stanford University
  • Overall Contact(s)
    • Clete A Kushida, MD, PhD, 650-721-7560, clete@stanford.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.