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

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea; Atrial Fibrillation
• Interventions: Procedure: Cardiac Ablation for Atrial Fibrillation

• Registration Number: NCT03242720
• Lead Sponsor: Stanford University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Study Start: 2019-01-01
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Positive Airway Pressure	Cardiac Ablation for Atrial Fibrillation	Active positive airway pressure for treatment of Obstructive Sleep Apnea
Sham Positive Airway Pressure	Cardiac Ablation for Atrial Fibrillation	Sham positive airway pressure for treatment of Obstructive Sleep Apnea

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation recurrence	6 months after ablation	Risk of Atrial Fibrillation recurrence

Trial Locations

Locations (1)

Stanford Sleep Medicine Center; 🇺🇸 Redwood City, California, United States