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The Conveyor Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893578
Recruitment Status : Unknown
Verified April 2019 by Synecor, LLC.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Synecor, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Mitral Valve Disease Mitral Valve Regurgitation Heart Failure Device: Mitral valve-in-valve Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Device: Synecor Conveyor System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human Safety Study of the Synecor Conveyor System Used for Delivery of a Minimally Invasive Mitral Valve
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Correct Positioning of Implant [ Time Frame: 30 Days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893578


Contacts
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Contact: Lauren Baker, PhD 9787643434 lbaker@boston-biomedical.com

Sponsors and Collaborators
Synecor, LLC
More Information
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Responsible Party: Synecor, LLC
ClinicalTrials.gov Identifier: NCT03893578    
Other Study ID Numbers: SYN-FIH-001
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Synecor, LLC:
Conveyor System
Sapien 3
cardiovascular disease
 TMVR
failing valve
failing bioprosthetic valve
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases