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Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients (OSA-AFIB)

Primary Purpose

Obstructive Sleep Apnea, Atrial Fibrillation

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cardiac Ablation for Atrial Fibrillation

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Stanford Sleep Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Positive Airway Pressure

Sham Positive Airway Pressure

Arm Description

Active positive airway pressure for treatment of Obstructive Sleep Apnea

Sham positive airway pressure for treatment of Obstructive Sleep Apnea

Outcomes

Primary Outcome Measures

Atrial Fibrillation recurrence

Risk of Atrial Fibrillation recurrence

Secondary Outcome Measures

Full Information

NCT ID

NCT03242720

First Posted

August 4, 2017

Last Updated

May 17, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03242720

Brief Title

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

Acronym

OSA-AFIB

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Funding issues

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Positive Airway Pressure

Arm Type

Active Comparator

Arm Description

Active positive airway pressure for treatment of Obstructive Sleep Apnea

Arm Title

Sham Positive Airway Pressure

Arm Type

Sham Comparator

Arm Description

Sham positive airway pressure for treatment of Obstructive Sleep Apnea

Intervention Type

Procedure

Intervention Name(s)

Cardiac Ablation for Atrial Fibrillation

Intervention Description

Ablation of arrhythmia focus in the heart for atrial fibrillation

Primary Outcome Measure Information:

Title

Atrial Fibrillation recurrence

Description

Risk of Atrial Fibrillation recurrence

Time Frame

6 months after ablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clete A Kushida, MD, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Sleep Medicine Center

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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