Heart Failure, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Regurgitation
Conditions
Keywords
Conveyor System, Sapien 3, cardiovascular disease, TMVR, failing valve, failing bioprosthetic valve
Brief summary
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.
Detailed description
This is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the Conveyor System can safely provide left ventricular access to deliver an Edwards SAPIEN 3 TAVR valve into the mitral valve position in a valve-in-valve procedure. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).
Interventions
DEVICEMitral valve-in-valve
The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.
Sponsors
Synecor, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Device: Synecor Conveyor System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is able and willing to comply with all assessments in the study. 2. Subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form. 3. Age of Subject is ≥18. 4. Estimated life expectancy \>6 months. 5. Patients demonstrated to have symptomatic post-therapeutic mitral valve dysfunction as determined at diagnostic cardiac catheterization, echocardiography, and/or MR and a mitral valve annulus suitable for a valve in valve transcatheter valve replacement procedure using the Edwards SAPIEN 3™ TAVR device based on diagnostic cardiac catheterization, echocardiography and/or MR imaging. 6. Patient has been evaluated by a Heart Team and judged to be a candidate for mitral valve in valve procedure. 7. Patient has femoral and iliac artery dimensions sufficient to accept the study device (\>6 mm). 8. Patient is potential surgical candidate.
Exclusion criteria
1. Patients with any clinical presentation that will exclude them from receiving a Edwards SAPIEN 3™ percutaneous valve. 2. Patients with vascular disease that would preclude navigation of the Conveyor System. 3. Patients who do not desire to participate in the study. 4. Patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study. 5. Patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement. 6. Patient requires urgent or emergent treatment. 7. Patient has significant aortic valve disease or previous aortic valve replacement. 8. Pregnant patients (must have negative pregnancy test).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Positioning of Implant | 30 Days | The ability of the Conveyor System to safely position the valve delivery system to facilitate correct positioning of the implant without causing any serious adverse events through 30-day follow up. Cineangiography will be used in delivery to ensure that the implant is orthogonal to the mitral valve annulus and centered within it from multiple views. The patient will be seen in the clinic in a routine follow-up to ascertain any untoward clinical signs or symptoms. |
Contacts
Primary ContactLauren Baker, PhD
Outcome results
None listed