Clinical trial NCT03242720: Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients
Official title: 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: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Atrial Fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial Fibrillation recurrence
timeFrame: 6 months after ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
Study officials:
affiliation: Stanford University
name: Clete A Kushida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: