Clinical trial NCT03893578: The Conveyor Study
Official title: First in Human Safety Study of the Synecor Conveyor System Used for Delivery of a Minimally Invasive Mitral Valve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Insufficiency
Mitral Valve Disease
Mitral Valve Regurgitation
Heart Failure
Keywords: Conveyor System
Sapien 3
cardiovascular disease
TMVR
failing valve
failing bioprosthetic valve
Lead sponsor: Synecor, LLC
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: Synecor Conveyor System
Primary purpose: TREATMENT

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Correct Positioning of Implant
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: