Trials / Not Yet Recruiting
Not Yet RecruitingNCT07123766
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
Detailed description
The PoliaValve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single-arm, open label, non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PoliaValve (Aortic) | Aortic Valve Replacement |
Timeline
- Start date
- 2025-11-15
- Primary completion
- 2027-12-30
- Completion
- 2027-12-30
- First posted
- 2025-08-14
- Last updated
- 2025-08-14
Source: ClinicalTrials.gov record NCT07123766. Inclusion in this directory is not an endorsement.