Trials / Completed
CompletedNCT02324920
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DDD-CLS | |
| DEVICE | ODO |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2020-04-01
- Completion
- 2020-07-01
- First posted
- 2014-12-24
- Last updated
- 2021-11-17
- Results posted
- 2021-11-17
Locations
24 sites across 6 countries: Canada, France, Italy, Netherlands, Portugal, Spain
Source: ClinicalTrials.gov record NCT02324920. Inclusion in this directory is not an endorsement.