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Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study (PRELUDE)

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: NCT02768402
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Caisson Interventional LLC

Brief Summary:
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Caisson TMVR System Not Applicable

Detailed Description:
The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
Study Start Date : June 2016
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Treatment Arm
All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study.
Device: Caisson TMVR System
Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.




Primary Outcome Measures :
  1. Number of patients without Major Adverse Events (MAEs) [ Time Frame: 30 days ]
    Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days


Secondary Outcome Measures :
  1. Number of patients with successful delivery and implantation of the prosthetic valve (technical success) [ Time Frame: Intraoperative ]
    Successful delivery and retrieval of the transcatheter mitral valve delivery system; deployment and correct positioning (via intraoperative imaging) in the appropriate anatomic location of prosthetic valve with no requirement for additional surgery

  2. Number of living, stroke-free patients with prosthetic valve in place (device success) [ Time Frame: 30 days ]
    Patient is alive, stroke-free, original intended device in place (echo), no mitral valve surgical re-intervention required



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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:

  • Has severe mitral regurgitation
  • New York Heart Association (NYHA) Class II, III, IVa or heart failure
  • High risk for cardiovascular surgery

Exclusion Criteria:

  • Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
  • Left ventricular end diastolic dimension > 7cm
  • Left ventricular outflow tract obstruction
  • Severe right ventricular dysfunction
  • Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

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): NCT02768402


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Delray Medical Center
Delray Beach, Florida, United States, 33484
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07962
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
OhioHealth
Columbus, Ohio, United States, 43214
United States, Tennessee
Saint Thomas Heart
Nashville, Tennessee, United States, 37205
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Health Services
Seattle, Washington, United States, 98122
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Caisson Interventional LLC
Investigators
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Study Director: Mathew Williams, MD NYU Langone Medical Center
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Responsible Party: Caisson Interventional LLC
ClinicalTrials.gov Identifier: NCT02768402    
Other Study ID Numbers: 001
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Caisson Interventional LLC:
Mitral Valve Regurgitation
Primary MR
Secondary MR
MR
Heart Failure
Structural Heart
Secondary Mitral Valve Regurgitation
Primary Mitral Valve Regurgitation
Transseptal
Transcatheter
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases