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

The primary endpoint is to prove that the difference in AF occurrence between severe SA patients versus non severe is greater or equal to 6 % after 12 Months follow-up. AF will be measured using the Fallback Mode Switch duration (FMS) and SA using the Respiratory Disturbance Index (RDI), both stored in the device.

The co-primary endpoint is to evaluate the rate of composite endpoint of all major serious adverse events as reported by the investigator over 18 months follow up corresponding to death, myocardial infarction, stroke and re-intervention (at least one of the 4 types of major SAE per patient). These major SAE will be also assessed by type.

The prevalence of SA will be calculated considering the sum of SA patients out of all patients having performed the given follow up.

Patients known as treated for SAS could not be taken into account in a secondary analysis.

Same method as described in outcome 1 except in this secondary objective, a patient will be considered as presenting subclinical AF when presenting between enrolment and a given follow up (M1, M6, M12 or M18) at least one fallback mode switch episode as following:

• 1st case: below or equal to 6 minutes in the same day
• 2nd case: between 6 minutes and 6 hours 17 in the same day
• 3rd case: strictly greater than 6 hours17 in the same day.

The definition and method are the same as described in outcome 1 except measurements will be performed at 1, 6 and 18 Months.

Same method as described in outcome 1 except in this secondary objective, a patient will be considered as presenting AF based on the FMS burden value. FMS burden is the time spent in fallback mode switch divided by the follow up period in days. This FMS will be measured between 2 consecutives available follow up: enrolment and M1, then M1 and M6, M6 and M12, M12 and M18.

The AF episode diagnosed on clinical assessment will be collected in CRF at each follow up (M1, M6, M12 and M18). The RDI stored at the date of each AF event will be collected. We will then measure out of all AF events, how many of them are associated with a severe Sleep Apnea (RDI >=20).

The aim of this secondary objective was to observe how cardiologists in their routine practice would use this new information offered by SAM function (RDI). In particular, the physician process to decide whether he/she refers the patient to a sleep specialist will be observed. At each follow up the cardiologist asked the patient whether he/she had any visit to a sleep specialist since the last follow-up (pneumologist, neurologist, Ear Nose and Throat specialist …).

For the patients evaluable at each of the scheduled visits, the number and percentage of patients who made a visit to a sleep specialist were to be presented overall and by the type of specialist (pneumologist, neurologist, Ear Nose and Throat specialist, etc) for severe and non-severe SA patients.

The aim of this secondary objective was to observe whether patients will undergo further sleep investigations (Polygraphy, Polysomnography…).

At each follow up the cardiologist asked the patient whether he/she had any sleep exam since the last follow-up (Polygraphy, Polysomnography, oxymetry). Then the data was filled in the patient CRF.

For the patients evaluable at each of the scheduled visits, the number and percentage of patients who underwent a sleep exam were to be presented overall and by the type of test (Polygraphy, Polysmonography, Oxymetry, etc).

At each follow-up visit, the patients who did undergo aSleep Apnea test and were diagnosed as having SA were considered a patient with SA as per Lab results.

The association of SA as diagnosed by Lab results with that of SA as measured based on RDI values were presented based on true positive/negative and false positive/negative.

At each follow up the cardiologist asked the patient whether he/she had any treatment for Sleep Apnea. Then the data was filled in the patient CRF. Then at each time-point, the number and percentages of evaluable patients who had been treated for SA will be presented by the definition of severe/non-severe SA

The aim of this secondary objective was to assess how the SA treatment impacted the level of RDI stored in the device. It was observed in different studies that, to assess the benefit of SA treatments, a follow-up period of 4 to 16 weeks was recommended.

The aim of this secondary objective was to assess how SA treatment impacted the AF using FMS duration. It was observed in different studies that, to assess the benefit of SA treatments, a follow-up period of 4 to 16 weeks was recommended.

The RDI variability was determined with the measure of Standard Deviation calculated based on all the daily RDI values. The relationship between this measure of RDI variability with RDI, SA diagnosis and SA treatment will be assessed. A high value of SD indicated greater instability in daily RDI values compared to a lower SD.

The aim is to investigate the severity of SA according to the patient's pacing indications. The implant indication will be collected at enrollment and is described as II° AVB, III° AVB, Syncope, Brady-Tachy Syndrome, Sinus Node Dysfunction, Carotid Sinus Syndrome. For each implant indication, the number and percentages of severe and non-severe SA patients will be presented.

Serious adverse events will be collected to verify the absence of unanticipated adverse effects due to the device.

Evaluate at given time points any correlation between data stored in the device and clinical assessment related to the primary and secondary endpoints.