Clinical trial NCT01922726: Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)
Official title: Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 1257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient eligible for implantation of a dual-chamber pacemaker (primo-implant, replacement, upgrade) according to current available guidelines Patient with REPLY 200 DR implantation performed. Patient who provides signed and dated informed consent according to the local laws and regulations

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient eligible for implantation of a dual-chamber pacemaker according to current available guidelines
* Patient with REPLY 200 DR implantation performed
* Patient who provides signed and dated informed consent (according to the laws and regulations of the country in which the observational study is conducted)

Exclusion Criteria:

* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for routine follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-years old)
* Patient is pregnant
* Patient is forfeiture of freedom or under guardianship

Primary outcomes:
measure: Evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in the pacemaker.
timeFrame: 12 months
measure: Collect all major serious adverse events as reported by the investigator during the duration of the study corresponding to death, myocardial infarction, stroke and re- intervention.
timeFrame: 18 months
Secondary outcomes:
measure: Assess prevalence of SA in pacemaker population based on RDI measured and stored in the pacemaker at 1, 6, 12 and 18 Months.
timeFrame: 1, 6, 12 and 18 months
measure: Evaluate at 1, 6, 12 and 18 Months follow-up the association between subclinical atrial fibrillation and sleep apnea based on data measured and stored in the pacemaker.
timeFrame: 1, 6, 12 and 18 months
measure: Evaluate at 1, 6 and 18 Months follow-up the association between AF and SA severity based on data measured and stored in the pacemaker (qualitative data).
timeFrame: 1, 6 and 18 months
measure: Evaluate at 1, 6, 12 and 18 Months follow-up the association between AF and SA severity based on data measured and stored in the pacemaker (quantitative data).
timeFrame: 1, 6, 12 and 18 months
measure: Evaluate at 1, 6, 12 and 18 Months follow-up the association between AF diagnosed on clinical assessment (ECG, holter, AF related serious adverse events: cardioversion, ablation…) and SA severity.
timeFrame: 1, 6, 12 and 18 months
measure: Occurrence of patients referred to sleep specialists - Occurrence of patients referred to sleep specialists. - Occurrence of patients having sleep exam during the study. - Occurrence patients being treated for SA during the study.
timeFrame: 1, 6, 12 and 18 months
measure: Occurrence of patients having sleep exam during the study
timeFrame: 1, 6, 12 and 18 months
measure: Compare the sleep lab results with the RDI stored in the pacemaker
timeFrame: 1, 6, 12 and 18 months
measure: Occurrence of patients being treated for SA during the study
timeFrame: 1, 6, 12 and 18 months
measure: Compare RDI before and after SA treatment
timeFrame: 1, 6, 12 and 18 months
measure: Compare AF (using FMS duration and AF related hospitalization) before and after SA treatment when the patient is treated
timeFrame: 1, 6, 12 and 18 months
measure: Stability of the RDI.
timeFrame: 1, 6, 12 and 18 months
measure: Association between SA severity and indication for pacemaker's implantation.
timeFrame: 18 months
measure: Collect serious adverse events throughout the study.
timeFrame: 1, 6, 12 and 18 months
measure: Evaluate at given time points any correlation between data stored in the device and clinical assessment related to the primary and secondary endpoints.
timeFrame: 1, 6, 12 and 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Del Mar
Study officials:
affiliation: Hospital Del Mar, Barcelona, Spain
name: Julio MARTI ALMOR, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marti-Almor J, Marques P, Jesel L, Garcia R, Di Girolamo E, Locati F, Defaye P, Venables P, Dompnier A, Barcelo A, Nagele H, Burri H. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study. Heart Rhythm. 2020 Feb;17(2):195-202. doi: 10.1016/j.hrthm.2019.09.001. Epub 2019 Sep 4.