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Completed

NCT Number: NCT03039855

Tiara™ Transcatheter Mitral Valve Replacement Study

To evaluate the safety and 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

Kerckhoff Klinik Herzzentrum-Herzchirurgie, Bad Nauheim, Germany

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About this study

The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe mitral regurgitation
  • High surgical risk for open mitral valve surgery
  • Subject meets anatomical eligibility criteria

Exclusion criteria

  • Deemed too frail by objective frailty assessments
  • Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
  • Unsuitable cardiac structure
  • Clinically significant untreated Coronary Artery Disease (CAD)
  • Subjects on chronic dialysis
  • Pregnant or planning pregnancy within next 12 months
  • Documented bleeding or coagulation disorders
  • Active infections requiring antibiotic therapy
  • Subjects with a life expectancy less than 12 months

Treatment and study plan

TIARA valve and transapical delivery system

Device

Transcatheter mitral valve replacement

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

Primary outcomes

  1. Freedom from all-cause mortality

    Time frame: 30 days

  2. Freedom from major adverse events

    Time frame: 30 Days

  3. Reduction of Mitral Regurgitation to optimal or acceptable

    Time frame: 30 days

Secondary outcomes

  1. Freedom from all-cause mortality

    Time frame: 90 days, 180 days, one year and annually to five years

  2. Freedom from major adverse events

    Time frame: 90 days, 180 days, one year and annually to five years

  3. Technical success

    Time frame: Day 0

    Per MVARC criteria

  4. Procedural success

    Time frame: 30 days

    Per MVARC criteria

  5. Device success

    Time frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years

    Per MVARC criteria

  6. NYHA Functional Class

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

    Number of subjects with improved NYHA class

  7. 6 Minute Walk Test

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

    Increase in distance (m) from baseline

  8. Kansas City Cardiomyopathy Questionnaire

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

    Improvement in quality of life

  9. Hemodynamic performance

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

    Assessed by echocardiography

  10. Patient success

    Time frame: 1 year

    Per MVARC Criteria

Sponsors and collaborators

Lead sponsor

Shockwave Medical, Inc.

Industry

Registry information

Official study title

Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)

Acronym: TIARA-II

Important dates

Study start
2017
Primary completion
2019
Study completion
2024
First posted
Feb 1, 2017
Registry last updated
Sep 29, 2025

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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