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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

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE July 20, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03661398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caisson Transcatheter Mitral Valve Replacement (TMVR)
Official Title  ICMJE Clinical Investigation of the Caisson Transcatheter Mitral Valve Replacement (TMVR) System for Percutaneous Mitral Valve Replacement in Patients With Symptomatic Mitral Regurgitation
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Regurgitation
  • Mitral Valve Disease
  • Mitral Valve Failure
  • Mitral Disease
  • Valve Heart Disease
  • Valve Disease, Heart
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: Transcatheter Mitral Valve Replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT03661398
Other Study ID Numbers  ICMJE INT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Caisson Interventional LLC
Study Sponsor  ICMJE Caisson Interventional LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mat Williams, M.D. NYU Langone Medical Center
PRS Account Caisson Interventional LLC
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP