Mitral Regurgitation
Conditions
Brief summary
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question\[s\] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status. Participants will be implanted with the Anchord device.
Interventions
DEVICEAnchord device implantation
Anchord Mitral Chordal Repair device implantation
Sponsors
Lifecord Otd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe symptomatic degenerative mitral regurgitation (grade 3+) * High surgical risk for open-heart mitral valve repair or replacement * Suitable anatomy for transcatheter chordal repair as determined by the treating physician * Ability to undergo required echocardiographic and fluoroscopic imaging * Ability to provide informed consent
Exclusion criteria
* Active endocarditis or systemic infection * Severe left ventricular dysfunction (LVEF \<30%) * Significant non-mitral valvular disease requiring intervention * Severe mitral annular calcification (MAC) * Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava * Cerebrovascular events (TIA, CVA) or thromboembolic events within the previous 6 months. * Renal insufficiency * Inability to undergo required imaging or access * Inability to tolerate standard anticoagulation or antithrombotic regimen * Rheumatic mitral valve disease * Co-morbid condition limiting life expectancy or study completion * Pregnancy * Participation in another clinical trial * Previous device treatment for MR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful device implantation assessed by imaging [Technical Success] | Day 0 - Procedure day | Successful delivery, deployment, and secure fixation of the device assessed during the procedure. |
| Incidence of device or procedure related major adverse events [Safety] | 30 days post-procedure. | Freedom from device- or procedure-related major adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MR reduction | 30 days | Mitral regurgitation reduction of 1 or more degrees |
| NYHA class | 90 days post procedure | Improvement in NYHA functional by 1 or more degrees |
Contacts
CONTACTShaily Shohat
Outcome results
None listed