Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Not Applicable

Active, not recruiting

Conditions: Mitral Valve Regurgitation

Interventions: Device: Mitral valve replacement

Registration Number: NCT02276547

Lead Sponsor: Shockwave Medical, Inc.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 27

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Mitral valve replacement	Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system

Primary Outcome Measures

Name	Time	Method
Freedom From All-cause Mortality and Major Adverse Events	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 Outcome Measures

Name	Time	Method
Number and Percentage of Subjects With Progression of Heart Failure	One year	Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
Performance	30 days, 90 days, 180 days and annually for five years	Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures
Individual 30 Day Rates of Device and Procedure Related Major Adverse Events	30 days	1. All mortality 2. All stroke 3. Residual MR \> mild (1+) 4. Life threatening bleeding 5. Acute kidney injury Grade 3 6. New pacemaker/LBBB 7. Coronary occlusion/myocardial infarction 8. Urgent/emergent surgery or reintervention
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	Mitral regurgitation \< moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient \< 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures
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	Number of days alive and not hospitalized

Trial Locations

Locations (10): Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
ZNA Middelheim
🇧🇪
Antwerpen, Belgium
University of Alberta
🇨🇦
Edmonton, Alberta, Canada
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Washington University
🇺🇸
Saint Louis, Missouri, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States