Trials / Completed
CompletedNCT01537718
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | REPLY 200 | REPLY 200 pacemaker |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2012-02-23
- Last updated
- 2013-07-17
Locations
5 sites across 2 countries: France, Spain
Source: ClinicalTrials.gov record NCT01537718. Inclusion in this directory is not an endorsement.