Observational registry for patients treated with the NeoChord Artificial Chordae System
Official title: The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Run by NeoChord · NCT04190602 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | NeoChord Industry-sponsored |
| Locations | 5 sites (Bonn and 4 other locations) |
| Status | Recruiting |
| Started | February 9, 2020 |
| Main results expected | October 2022 |
| Study ends | December 2027 |
| Registry record updated | July 10, 2020 |
| Trial ID | NCT04190602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with heavily calcified valves, active bacterial endocarditis, or complex mechanisms of mitral regurgitation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies involving similar approaches to mitral valve repair have shown promising results, indicating potential for success in this registry.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves
This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.
-
Investigating multiple and mixed heart valve diseases
This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.
-
Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
-
Abbott Cephea registry for mitral valve disease
Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.
-
Left atrial shunt to help after mitral valve surgery
This study tests whether making a small opening between the left and right atria during mitral valve repair can relieve high left atrial pressure for adults with primary mitral regurgitation.
-
Impact of mitral valve surgery on ventricular arrhythmias
This study is testing how mitral valve surgery helps people with mitral valve prolapse and arrhythmias by looking at their heart health before and after the operation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.