CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Adaptive Servo-Ventilation +1 moredevice
Likely dose
Not stated in record
Key inclusion· 3
  • Age greater than 18 years
  • Successful electrical or chemical cardioversion within previous 2 weeks
  • More than 2 episodes of symptomatic AF in the previous 6 months
Key exclusion· 11
  • Currently on PAP therapy
  • Moderate to severe pulmonary disease
  • History of cerebrovascular accident, transient ischemic attack, neuromuscular disease, or diaphragmatic paralysis
  • Severe cardiac disease including LVEF <40% or greater than mild to moderate valvular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00263757
NCT00263757N/ACompleted

A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea

Mayo Clinic·interventional·Posted Dec 9, 2005·Updated Aug 1, 2014

In Brief

A clinical study evaluating Adaptive Servo-Ventilation and Usual Care for Sleep Apnea and Atrial Fibrillation. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2005
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.6 years ago

Interventions

Adaptive Servo-Ventilationdevice

Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.

Usual Careother

Subjects randomized to this arm received medical management as prescribed by their cardiologist.