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Caisson Transcatheter Mitral Valve Replacement (TMVR) (INTERLUDE)

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: NCT03661398
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Caisson Interventional LLC

Brief Summary:
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Valve Disease Mitral Valve Failure Mitral Disease Valve Heart Disease Valve Disease, Heart Device: Transcatheter Mitral Valve Replacement 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. 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. The feasibility of percutaneous MV replacement has been demonstrated in early feasibility studies. 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 information on the safety and performance of this system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Caisson Transcatheter Mitral Valve Replacement (TMVR) System for Percutaneous Mitral Valve Replacement in Patients With Symptomatic Mitral Regurgitation
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2025

Arm Intervention/treatment
Experimental: Transcatheter Mitral Valve Replacement
Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System
Device: Transcatheter Mitral Valve Replacement
All eligible patients will be in the treatment arm for treatment with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System. There is no control (comparator) arm for this study.
Other Name: Caisson Transcatheter Mitral Valve Replacement (TMVR) System




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: Intra-operative ]
    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; transient ischemic 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): NCT03661398


Locations
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United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Caisson Interventional LLC
Investigators
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Principal Investigator: Mat Williams, M.D. NYU Langone Medical Center

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Responsible Party: Caisson Interventional LLC
ClinicalTrials.gov Identifier: NCT03661398     History of Changes
Other Study ID Numbers: INT-001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Caisson Interventional LLC:
Percutaneous mitral valve replacement
Trans-septal mitral valve replacement
Transcatheter mitral valve replacement
TMVR
Primary MR
Secondary MR
Structural Heart Disease
Heart Failure
Degenerative Mitral Valve Disease
Functional Mitral Valve Disease
Additional relevant MeSH terms:
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Heart Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Cardiovascular Diseases