Trials / Suspended
SuspendedNCT02545582
VITARIA Registry Study
- Status
- Suspended
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.
Detailed description
Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VITARIA System | Implantable vagus nerve stimulator |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-08-01
- Completion
- 2019-12-01
- First posted
- 2015-09-10
- Last updated
- 2017-01-31
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02545582. Inclusion in this directory is not an endorsement.