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



Status:Not yet recruiting
Conditions:Atrial Fibrillation, Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:January 2019
End Date:December 2020
Contact:Clete A Kushida, MD, PhD
Email:clete@stanford.edu
Phone:650-721-7560

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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.

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.

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
We found this trial at
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Redwood City, California 94063
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Redwood City, CA
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