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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Sorin Group
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01922726
First received: August 1, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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
Bradycardia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with severe and non severe SA using the RDI measurement [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measure time spent in AF in severe SA population and in non severe SA population [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measure AF before and after SA treatment [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Measure the RDI variation day after day [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Number of patients with severe SA according to the patient pacing indication [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Number and type of Adverse Events as a Measure of Safety [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Measure SA before and after AF treatment [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients being treated for SA after being included [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1078
Study Start Date: July 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922726

Contacts
Contact: Virginie Mercier - Study manager +33616441380 virginie.mercier@sorin.com

Locations
Spain
Hospital Del Mar Recruiting
Barcelona, Spain
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Julio MARTI ALMOR, Dr Hospital Del Mar, Barcelona, Spain
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01922726     History of Changes
Other Study ID Numbers: RBSY03 - RESPIRE
Study First Received: August 1, 2013
Last Updated: August 12, 2013
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Italy: Ministry of Health
Portugal: National Commission of Data Protection
Portugal: Ethic Commission and Hospital Administration of each hospital involved in the study
Portugal:National Health Authority (INFARMED)
Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014