Trials / Recruiting
RecruitingNCT05876000
Corheart 6 LVAS Study
Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation. The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Corheart 6 Left Ventricular Assist System | Implantation of left ventricular assist device for mechanical circulatory support |
Timeline
- Start date
- 2024-05-14
- Primary completion
- 2026-12-30
- Completion
- 2031-06-30
- First posted
- 2023-05-25
- Last updated
- 2026-01-08
Locations
11 sites across 3 countries: Austria, Germany, Italy
Source: ClinicalTrials.gov record NCT05876000. Inclusion in this directory is not an endorsement.