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

NCT01922726 | Completed

• 1 other identifier: RBSY03 - RESPIRE
• Study Type: observational
• Target: 1,257
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

  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).

  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).

  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.

  1, 6, 12 and 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (1)

Hospital Del Mar

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 31493591 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julio MARTI ALMOR, Dr

  Hospital Del Mar, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 14, 2013
• Study Start: July 1, 2013
• Primary Completion: March 20, 2017
• Study Completion: December 31, 2017
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

ES (1)