Observational registry for patients treated with the NeoChord Artificial Chordae System
The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NeoChord Industry-sponsored |
| Locations | 5 sites (Bonn and 4 other locations) |
| Trial ID | NCT04190602 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the 5-year outcomes of patients with degenerative mitral valve disease who have been treated using the NeoChord Artificial Chordae Delivery System, Model DS1000. The study will include both prospective and retrospective enrollment and will not require any additional invasive procedures beyond those typically associated with standard mitral valve repair. It is designed to gather real-world data on the effectiveness and safety of this treatment in a multicenter setting.
Who should consider this trial
Good fit: Ideal candidates are individuals with Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation who have undergone the procedure since December 31, 2016.
Not a fit: Patients with heavily calcified valves, active bacterial endocarditis, or complex mechanisms of mitral regurgitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the NeoChord system for patients with mitral valve disease.
How similar studies have performed: Other studies involving similar approaches to mitral valve repair have shown promising results, indicating potential for success in this registry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation * Study procedure completed after 31 December 2016 Exclusion Criteria: * Heavily calcified valves * Valvular retraction with severely reduced mobility * Active bacterial endocarditis * Complex mechanism of MR (leaflet perforation, etc.) * Significant tethering of leaflets * Inflammatory valve disease
Where this trial is running
Bonn and 4 other locations
- University of Bonn — Bonn, Germany (Recruiting)
- CVC Frankfurt — Frankfurt, Germany (Recruiting)
- University of Mainz — Mainz, Germany (Recruiting)
- Hippokration Hospital — Athens, Greece (Recruiting)
- Triemli Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Andres Beiras Fernandez, MD PhD — Johannes Gutenberg University Mainz
- Study coordinator: Alexandar Jonkers
- Email: ajonkers@neochord.com
- Phone: +31 610740977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.