Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (TIARA-I)

Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: Mitral valve replacement

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, B 2060
    • Zna Middelheim
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Michigan
    • Detroit, Michigan, United States, 48188
      • Henry Ford Health System
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system	Device: Mitral valve replacement; Transcatheter mitral valve replacement; Other Names: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From All-cause Mortality and Major Adverse Events	Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention	From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Subjects With Progression of Heart Failure	Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation	One year
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	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
Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events	All mortality; All stroke; Residual MR > mild (1+); Life threatening bleeding; Acute kidney injury Grade 3; New pacemaker/LBBB; Coronary occlusion/myocardial infarction; Urgent/emergent surgery or reintervention	30 days
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter	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	Post procedure
Days Alive and Out of Hospital	Number of subjects alive and not hospitalized	At one year
Performance - KCCQ	Clinical performance as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ). Quality-of-life questionnaire for patients with heart failure. Scores range from 0 to 100: 0-24 is very poor to poor, 25-49 is poor to fair, 50-74 is fair to good, 75-100 is good to excellent.	30 days, 90 days, 180 days and annually for five years
Performance - NYHA	Clinical performance as measured by New York Heart Association (NYHA) Classification of heart failure. Severity is classified in four classes (I-IV). Class I = mild, no limitation of physical activity. Class II = mild with slight limitation of physical activity. Class III = moderate with marked limitation of physical activity. Class IV = severe with inability to carry out any physical activity without discomfort.	30 days, 90 days, 180 days and annually for five years
Performance - 6MWT	Clinical performance as measured by 6-Minute Walk Test (6MWT) measures the maximum distance a person can walk along a flat, straight 30 meter course in 6 minutes.	30 days, 90 days, 180 days and annually for five years

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.
• Investigators: Study Chair: Anson Cheung, MD, University of British Columbia

Publications and helpful links

General Publications

• Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
• De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
• Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.

Helpful Links

• Company website with product information

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2015
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimated): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Degenerative; Heart valve; Transapical; Regurgitation; Mitral; Functional; Transcatheter; Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Digestive System Diseases; Gastrointestinal Diseases; Heart Valve Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Mitral Valve Insufficiency
• Other Study ID Numbers: 047-CPT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO