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

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ClinicalTrials.gov Identifier: NCT01922726
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova

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.

Condition or disease
Bradycardia

Study Type : Observational
Actual Enrollment : 1257 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients
Actual Study Start Date : July 2013
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Percentage of severe Sleep Apnea (SA) versus non severe SA patients having Atrial Fibrillation (AF) based on data stored in the pacemaker over 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percentage of patients with severe and non severe SA using the RDI measurement [ Time Frame: 6, 12, 18, and 24 months ]
  2. Percentage of severe SA versus non severe SA patients having sub clinical AF based on data stored in the pacemaker [ Time Frame: 6, 12, 18, and 24 months ]
  3. Percentage of severe SA versus non severe SA patients having AF based on data stored in the pacemaker [ Time Frame: 6, 18, and 24 months ]
  4. Measure time spent in AF in severe SA population and in non severe SA population [ Time Frame: 6, 12, 18, and 24 months ]
  5. Percentage of severe SA versus non severe SA patients (using pacemaker index) having AF diagnosed on clinical assesment [ Time Frame: 6, 12, 18, and 24 months ]
  6. Measure AF before and after SA treatment [ Time Frame: 6, 12, 18, and 24 months ]
  7. Measure the RDI variation day after day [ Time Frame: 6, 12, 18, and 24 months ]
  8. Number of patients with severe SA according to the patient pacing indication [ Time Frame: 6, 12, 18 and 24 months ]
  9. Number and type of Adverse Events as a Measure of Safety [ Time Frame: 6, 12, 18 and 24 months ]
  10. Measure SA before and after AF treatment [ Time Frame: 6, 12, 18, and 24 months ]
  11. Percentage of patients being treated for SA after being included [ Time Frame: 6, 12, 18, and 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922726


Locations
Spain
Hospital Del Mar
Barcelona, Spain
Sponsors and Collaborators
LivaNova
Investigators
Principal Investigator: Julio MARTI ALMOR, Dr Hospital Del Mar, Barcelona, Spain

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01922726     History of Changes
Other Study ID Numbers: RBSY03 - RESPIRE
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes