The Conveyor Study

NCT03893578 | Unknown FDA Device

• 1 other identifier: SYN-FIH-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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

Interventions

Mitral valve-in-valve DEVICE

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

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Synecor, LLC: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases

Central Study Contacts

Lauren Baker, PhD

CONTACT

9787643434; lbaker@boston-biomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device: Synecor Conveyor System

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04