NCT04190602 Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
| NCT ID | NCT04190602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NeoChord |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-02-09 |
| Primary Completion | 2022-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-02-09 with a primary completion date of 2022-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Andres Beiras Fernandez, MD PhD
PRINCIPAL INVESTIGATOR
Johannes Gutenberg University Mainz
Frequently Asked Questions
Who can join the NCT04190602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04190602 currently recruiting?
Yes, NCT04190602 is actively recruiting participants. Contact the research team at ajonkers@neochord.com for enrollment information.
Where is the NCT04190602 trial being conducted?
This trial is being conducted at Bonn, Germany, Frankfurt, Germany, Mainz, Germany, Athens, Greece and 1 additional location.
Who is sponsoring the NCT04190602 clinical trial?
NCT04190602 is sponsored by NeoChord. The principal investigator is Andres Beiras Fernandez, MD PhD at Johannes Gutenberg University Mainz. The trial plans to enroll 500 participants.