Trials / Recruiting
RecruitingNCT05655897
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GeminiOne Transcatheter Valve Edge-to-Edge Repair System | The transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body. |
Timeline
- Start date
- 2022-11-24
- Primary completion
- 2025-11-24
- Completion
- 2029-11-24
- First posted
- 2022-12-19
- Last updated
- 2024-06-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05655897. Inclusion in this directory is not an endorsement.