Trials / Unknown
UnknownNCT02645539
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- NuPulseCV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
Detailed description
This is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of the NuPulseCV iVAS. Data obtained from the study will be used to make device modifications, refine the patient population, and inform the design a future clinical trial suitable for assessing longer-term use in heart failure patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | intravascular ventricular assist system (iVAS) | A mechanical circulatory support device using the principles of counterpulsation. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-07-01
- Completion
- 2020-12-01
- First posted
- 2016-01-01
- Last updated
- 2019-11-13
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02645539. Inclusion in this directory is not an endorsement.