Trials / Unknown
UnknownNCT01621464
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
Closed Loop Stimulation for Neuromediated Syncope
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Spanish Society of Cardiology · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope. Furthermore, not only will be investigated if this system eradicates syncopes, but also if the number of presyncopal episodes is reduced.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacemaker with Closed Loop Stimulation (CLS sensor) | Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first) |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2012-06-18
- Last updated
- 2014-04-14
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01621464. Inclusion in this directory is not an endorsement.