Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker (DREAM)

LivaNova

Status and phase

Completed

Phase 3

Conditions

Bradycardia

Treatments

Device: REPLY 200

Study type

Interventional

Funder types

Industry

Identifiers

NCT01537718

IBSY04

Details and patient eligibility

About

The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

Full description

The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:

Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
Patients who provide signed and dated informed consent

Exclusion Criteria:

Inability to understand the purpose of the study or refusal to co-operate
Unavailability for scheduled 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 (women of childbearing potential should have a negative pregnancy test prior to enrolment)
Patient is forfeiture of freedom or under guardianship