NCT01922726

Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)

Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,257 (actual)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.

Detailed description

The object of the investigation relates to the function named Sleep Apnea Monitoring or SAM function. This function is part of the REPLY 200 DR pacemakers, whose intended use is cardiac pacing. Sleep Apnea Syndrom (SAS) causes serious social and economic problems, not only because of its high prevalence but also because it is associated with increased cardiovascular morbidity and mortality. Patients with Sleep Apnea often have arterial and pulmonary hypertension, a high risk of coronary artery disease, and heart failure, whereas a high percentage of patients show heart rhythm disturbances. In addition, these patients are at increased risk of being involved in traffic accidents, as well as suffering a decline in their family, social, and professional lives. Therefore, the prompt diagnosis of these patients could be of great importance. Today the gold standard for the diagnosis of SAS is overnight polysomnography (PSG) in a sleep laboratory. However, the shortage of sleep laboratories and the high cost of PSG render this method inadequate for widespread screening. For these reasons, in recent years, there have been attempts to develop alternative diagnostic with a view to simplify the diagnosis. Thanks to the feature SAM included in the pacemaker, sequences of respiratory cycles are analyzed to detect, to count and to report abnormal breathing events during the night. This analysis is based on the Minute Ventilation (MV) signal. The MV signal represents the real time expansion/contraction of the thorax of the patient. It is derived of the transthoracic impedance periodic measurements. The device is able to provide the physician with day-by-day Respiratory Disturbance Index (RDI) equal to the sum of events divided by the number of hours per night. Physician will also access to the total number of events over the previous night presented per hour.

Conditions

• Bradycardia

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-03-20
• Completion: 2017-12-31
• First posted: 2013-08-14
• Last updated: 2019-04-05

Locations

1 site across 1 country: Spain