An observational study in Bradycardia, sponsored by MicroPort CRM. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by MicroPort CRM · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,257 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
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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
Exclusion Criteria:
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.
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.
Time frame: 12 months
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.
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.
Time frame: 18 months
Assess prevalence of SA in pacemaker population based on RDI measured and stored in the pacemaker at 1, 6, 12 and 18 Months.
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.
Time frame: 1, 6, 12 and 18 months
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.
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.
Time frame: 1, 6, 12 and 18 months
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).
The definition and method are the same as described in outcome 1 except measurements will be performed at 1, 6 and 18 Months.
Time frame: 1, 6 and 18 months
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).
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.
Time frame: 1, 6, 12 and 18 months
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.
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).
Time frame: 1, 6, 12 and 18 months
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.
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.
Time frame: 1, 6, 12 and 18 months
Occurrence of patients having sleep exam during the study
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).
Time frame: 1, 6, 12 and 18 months
Compare the sleep lab results with the RDI stored in the pacemaker
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.
Time frame: 1, 6, 12 and 18 months
Occurrence of patients being treated for SA during the study
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
Time frame: 1, 6, 12 and 18 months
Compare RDI before and after SA treatment
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.
Time frame: 1, 6, 12 and 18 months
Compare AF (using FMS duration and AF related hospitalization) before and after SA treatment when the patient is treated
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.
Time frame: 1, 6, 12 and 18 months
Stability of the RDI.
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.
Time frame: 1, 6, 12 and 18 months
Association between SA severity and indication for pacemaker's implantation.
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.
Time frame: 18 months
Collect serious adverse events throughout the study.
Serious adverse events will be collected to verify the absence of unanticipated adverse effects due to the device.
Time frame: 1, 6, 12 and 18 months
Evaluate at given time points any correlation between data stored in the device and clinical assessment related to the primary and secondary endpoints.
Evaluate at given time points any correlation between data stored in the device and clinical assessment related to the primary and secondary endpoints.
Time frame: 1, 6, 12 and 18 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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