Trials / Active Not Recruiting
Active Not RecruitingNCT02803957
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 585 (estimated)
- Sponsor
- NeoChord · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeoChord DS1000 | Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000 |
| DEVICE | Surgical Mitral Valve Repair | Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae. |
Timeline
- Start date
- 2016-11-03
- Primary completion
- 2021-01-01
- Completion
- 2027-01-01
- First posted
- 2016-06-17
- Last updated
- 2026-04-08
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02803957. Inclusion in this directory is not an endorsement.