The Conveyor Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03893578
• Other study ID #: SYN-FIH-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: February 2020

Study information

• Verified date: April 2019
• Source: Synecor, LLC
• Contact: Lauren Baker, PhD
• Phone: 9787643434
• Email: lbaker[@]boston-biomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Mitral valve-in-valve
The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synecor, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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