Trials / Unknown
UnknownNCT05425628
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
European First in Human Study of the NeoChord Transcatheter Mitral Repair System to Assess Safety and Performance in Patients With Symptomatic Mitral Regurgitation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- NeoChord · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
Detailed description
The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of the NeoChord Transcatheter Mitral Repair System in treating subjects with symptomatic mitral regurgitation, who are at high risk for standard mitral valve surgery, by using a minimally invasive transcatheter mitral valve repair procedure. The NeoChord Transcatheter Mitral Repair System is indicated for use in patients with grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement. The intended purpose for the NeoChord Transcatheter Mitral Repair System is for repair of chordal elongation and rupture resulting in mitral valve prolapse.
Conditions
- Mitral Valve Insufficiency
- Mitral Valve Prolapse
- Degenerative
- Mitral Regurgitation
- Heart Valve Diseases
- Heart Diseases
- Cardiovascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeoChord Transcatheter Mitral Repair System (or "NeoChord System") | The NeoChord Transcatheter Mitral Repair System is a system of delivery devices and implantable Neochordae and Anchor. The system is designed to percutaneously deliver and deploy the implantable ePTFE sutures, "Neochordae" as artificial chordae at the mitral valve and connect them to the implantable ventricular anchor, "Anchor", using a catheter based system placed into the left side of the heart through the interatrial septum. |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-09-01
- Completion
- 2023-12-01
- First posted
- 2022-06-21
- Last updated
- 2022-06-21
Source: ClinicalTrials.gov record NCT05425628. Inclusion in this directory is not an endorsement.