BradycardiaNCT01922726
Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)
An observational study of Bradycardia, run by MicroPort CRM at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- How many people
- 1,257 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients
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.
Read the 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
- Medical subject headings
- Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion20 Mar 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julio MARTI ALMOR, Dr, Principal investigator, Hospital Del Mar, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922726
- Sponsor's protocol ID
- RBSY03 - RESPIRE
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2013
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31493591
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients
- ClinicalTrials.gov ID
- NCT01922726
- Acronym / sponsor ID
- RBSY03 - RESPIRE
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 12 months
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.
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.
Time frame: 18 months
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.
15 secondary outcomes
Assess prevalence of SA in pacemaker population based on RDI measured and stored in the pacemaker at 1, 6, 12 and 18 Months.
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.
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).
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).
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.
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.
Time frame: 1, 6, 12 and 18 months
Occurrence of patients having sleep exam during the study
Time frame: 1, 6, 12 and 18 months
Compare the sleep lab results with the RDI stored in the pacemaker
Time frame: 1, 6, 12 and 18 months
Occurrence of patients being treated for SA during the study
Time frame: 1, 6, 12 and 18 months
Compare RDI before and after SA treatment
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
Time frame: 1, 6, 12 and 18 months
Stability of the RDI.
Time frame: 1, 6, 12 and 18 months
Association between SA severity and indication for pacemaker's implantation.
Time frame: 18 months
Collect serious adverse events throughout the study.
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.
Time frame: 1, 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 31493591Marti-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio MARTI ALMOR, Dr principal investigator
Hospital Del Mar, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by MicroPort CRM at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.