The Conveyor Study

First in Human Safety Study of the Synecor Conveyor System Used for Delivery of a Minimally Invasive Mitral Valve

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Disease
• Intervention / Treatment: Device: Mitral valve-in-valve

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).

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Baker, PhD; Phone Number: 9787643434; Email: lbaker@boston-biomedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional Arm; Access, delivery, and retrieval of the Conveyor system with correct positioning of the valve delivery system to facilitate correct positioning of the implant at the mitral location in patients with a failing bioprosthetic valve.	Device: Mitral valve-in-valve; The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct Positioning of Implant	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.	30 Days

Collaborators and Investigators

• Sponsor: Synecor, LLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: cardiovascular disease; TMVR; Sapien 3; failing valve; failing bioprosthetic valve; Conveyor System
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: SYN-FIH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes