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

NCT03242720 | Withdrawn

• 1 other identifier: 41798
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation recurrence

  Risk of Atrial Fibrillation recurrence

  6 months after ablation

Study Arms (2)

Active Positive Airway Pressure

ACTIVE COMPARATOR

Active positive airway pressure for treatment of Obstructive Sleep Apnea

Procedure: Cardiac Ablation for Atrial Fibrillation

Sham Positive Airway Pressure

SHAM COMPARATOR

Sham positive airway pressure for treatment of Obstructive Sleep Apnea

Procedure: Cardiac Ablation for Atrial Fibrillation

Interventions

Cardiac Ablation for Atrial Fibrillation PROCEDURE

Ablation of arrhythmia focus in the heart for atrial fibrillation

Active Positive Airway Pressure; Sham Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Clete A Kushida, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)