Trials / Recruiting
RecruitingNCT06101888
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TaurusTrio™ Heart Valve System | The TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2024-07-31
- Completion
- 2029-07-31
- First posted
- 2023-10-26
- Last updated
- 2024-03-18
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06101888. Inclusion in this directory is not an endorsement.