| NCT ID | NCT04820764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CardioMech AS |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-07-27 |
| Primary Completion | 2026-09 |
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
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2021-07-27 with a primary completion date of 2026-09.
⚠ 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
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Eligibility Criteria
Inclusion Criteria: * Eighteen (18) years of age or greater * Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail * Intermediate or high surgical risk for mitral valve repair Exclusion Criteria: * History of rheumatic heart disease * History of prior endocarditis * History of prior repair or replacement of the mitral valve, or annuloplasty * Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment * Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
Contact & Investigator
Mathew Williams, MD
PRINCIPAL INVESTIGATOR
NYU Langone
Frequently Asked Questions
Who can join the NCT04820764 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 NCT04820764 currently recruiting?
Yes, NCT04820764 is actively recruiting participants. Contact the research team at jennifer.ruether@cardiomech.com for enrollment information.
Where is the NCT04820764 trial being conducted?
This trial is being conducted at Thousand Oaks, United States, Evanston, United States, Wichita, United States, Rochester, United States and 8 additional locations.
Who is sponsoring the NCT04820764 clinical trial?
NCT04820764 is sponsored by CardioMech AS. The principal investigator is Mathew Williams, MD at NYU Langone. The trial plans to enroll 25 participants.