Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Shockwave Medical, Inc.
- Enrollment
- 27
- Locations
- 10
- Primary Endpoint
- Freedom From All-cause Mortality and Major Adverse Events
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed Description
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery. A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States. Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe symptomatic mitral regurgitation (Stage D)
- •High surgical risk for open mitral valve surgery
- •Subject meets the anatomical eligibility criteria for available size(s)
- •NYHA Class III or IV heart failure
Exclusion Criteria
- •DMR deemed by the heart team to be operable.
- •Prohibitive risk, deemed too frail or listed for cardiac transplant.
- •Unsuitable cardiac structure
Outcomes
Primary Outcomes
Freedom From All-cause Mortality and Major Adverse Events
Time Frame: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Secondary Outcomes
- Number and Percentage of Subjects With Progression of Heart Failure(One year)
- Performance(30 days, 90 days, 180 days and annually for five years)
- Individual 30 Day Rates of Device and Procedure Related Major Adverse Events(30 days)
- Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter(Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years)
- Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention(30 days, 90 days, 180 days and annually to five years)
- Days Alive and Out of Hospital(At one year)