Trials / Recruiting
RecruitingNCT04190602
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- NeoChord · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
Detailed description
This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.
Conditions
- Mitral Regurgitation
- Mitral Valve Disease
- Mitral Valve Insufficiency
- Mitral Valve Prolapse
- Heart Valve Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeoChord Artificial Chordae Delivery System, Model DS1000 | The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease. |
Timeline
- Start date
- 2020-02-09
- Primary completion
- 2022-10-01
- Completion
- 2027-12-01
- First posted
- 2019-12-09
- Last updated
- 2020-07-10
Locations
5 sites across 3 countries: Germany, Greece, Switzerland
Source: ClinicalTrials.gov record NCT04190602. Inclusion in this directory is not an endorsement.