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The Conveyor Study

Primary Purpose

Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mitral valve-in-valve

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Conveyor System, Sapien 3, cardiovascular disease, TMVR, failing valve, failing bioprosthetic valve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is able and willing to comply with all assessments in the study.
Subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
Age of Subject is ≥18.
Estimated life expectancy >6 months.
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.
Patient has been evaluated by a Heart Team and judged to be a candidate for mitral valve in valve procedure.
Patient has femoral and iliac artery dimensions sufficient to accept the study device (>6 mm).
Patient is potential surgical candidate.

Exclusion Criteria:

Patients with any clinical presentation that will exclude them from receiving a Edwards SAPIEN 3™ percutaneous valve.
Patients with vascular disease that would preclude navigation of the Conveyor System.
Patients who do not desire to participate in the study.
Patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study.
Patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement.
Patient requires urgent or emergent treatment.
Patient has significant aortic valve disease or previous aortic valve replacement.
Pregnant patients (must have negative pregnancy test).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03893578

First Posted

March 26, 2019

Last Updated

April 3, 2019

Sponsor

Synecor, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03893578

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Synecor, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure

Keywords

Conveyor System, Sapien 3, cardiovascular disease, TMVR, failing valve, failing bioprosthetic valve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Device: Synecor Conveyor System

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Mitral valve-in-valve

Intervention Description

The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.

Primary Outcome Measure Information:

Title

Correct Positioning of Implant

Description

Time Frame

30 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able and willing to comply with all assessments in the study. Subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form. Age of Subject is ≥18. Estimated life expectancy >6 months. 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. Patient has been evaluated by a Heart Team and judged to be a candidate for mitral valve in valve procedure. Patient has femoral and iliac artery dimensions sufficient to accept the study device (>6 mm). Patient is potential surgical candidate. Exclusion Criteria: Patients with any clinical presentation that will exclude them from receiving a Edwards SAPIEN 3™ percutaneous valve. Patients with vascular disease that would preclude navigation of the Conveyor System. Patients who do not desire to participate in the study. Patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study. Patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement. Patient requires urgent or emergent treatment. Patient has significant aortic valve disease or previous aortic valve replacement. Pregnant patients (must have negative pregnancy test).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Baker, PhD

Phone

9787643434

lbaker@boston-biomedical.com

12. IPD Sharing Statement

Learn more about this trial

The Conveyor Study

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