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NCT Number: NCT02276547

Early Feasibility Study of the Neovasc Tiara™ Mitral Valve 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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZNA Middelheim, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitral valve replacement

Device

Transcatheter mitral valve replacement

Other names: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

Primary outcomes

  1. Freedom From All-cause Mortality and Major Adverse Events

    Time frame: From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)

    Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention

Secondary outcomes

  1. 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

    Time frame: 30 days, 90 days, 180 days and annually to 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

  2. Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events

    Time frame: 30 days

    • 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

  3. Number and Percentage of Subjects With Progression of Heart Failure

    Time frame: One year

    Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation

  4. Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter

    Time frame: Post procedure

    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

  5. Days Alive and Out of Hospital

    Time frame: At one year

    Number of subjects alive and not hospitalized

  6. Performance - KCCQ

    Time frame: 30 days, 90 days, 180 days and annually for five years

    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.

  7. Performance - NYHA

    Time frame: 30 days, 90 days, 180 days and annually for five years

    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.

  8. Performance - 6MWT

    Time frame: 30 days, 90 days, 180 days and annually for five years

    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.

Sponsors and collaborators

Lead sponsor

Shockwave Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: TIARA-I

Important dates

Study start
2015
Primary completion
2020
Study completion
2024
First posted
Oct 28, 2014
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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