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

September 23, 2025 updated by: Shockwave Medical, Inc.

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

To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik Herzzentrum-Herzchirurgie
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
      • Bad Rothenfelde, Germany, 49214
        • Schüchtermann-Klinik
      • Berlin, Germany, 13353
        • Deutches Herzzentrum Berlin
      • Bernau, Germany, 16321
        • Immanuel Klinikum Bernau und Herzzentrum Brandenburg
      • Dortmund, Germany, 44229
        • St.-Johannes-Hospital, Klinik für Innere Medizin I
      • Halle, Germany, 06120
        • Universitatsklinikum Halle
      • Hamburg, Germany, 20246
        • Universitasklinikum Hamburg-Eppendorf
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig
      • Rotenburg an der Fulda, Germany
        • Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
      • Stuttgart, Germany, 70174
        • Sana Herzchirurgie Stuttgart GmbH
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Medical Center
  • Italy
      • Massa, Italy, 54100
        • Fondazione Toscana 'Gabriele Monasterio'
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • San Donato Milanese, Italy, 20097
        • IRCCS Policlinico San Donato
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Edinburgh Heart Centre Royal Infirmary
      • London, United Kingdom, SE59RS
        • King's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Device: TIARA valve and transapical delivery system
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
Time Frame
Freedom from all-cause mortality
Time Frame: 30 days
30 days
Freedom from major adverse events
Time Frame: 30 Days
30 Days
Reduction of Mitral Regurgitation to optimal or acceptable
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from all-cause mortality
Time Frame: 90 days, 180 days, one year and annually to five years
90 days, 180 days, one year and annually to five years
Freedom from major adverse events
Time Frame: 90 days, 180 days, one year and annually to five years
90 days, 180 days, one year and annually to five years
Technical success
Time Frame: Day 0
Per MVARC criteria
Day 0
Procedural success
Time Frame: 30 days
Per MVARC criteria
30 days
Device success
Time Frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
Per MVARC criteria
Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
NYHA Functional Class
Time Frame: 30 days, 90 days, 180 days and once annually for five years
Number of subjects with improved NYHA class
30 days, 90 days, 180 days and once annually for five years
6 Minute Walk Test
Time Frame: 30 days, 90 days, 180 days and once annually for five years
Increase in distance (m) from baseline
30 days, 90 days, 180 days and once annually for five years
Kansas City Cardiomyopathy Questionnaire
Time Frame: 30 days, 90 days, 180 days and once annually for five years
Improvement in quality of life
30 days, 90 days, 180 days and once annually for five years
Hemodynamic performance
Time Frame: 30 days, 90 days, 180 days and once annually for five years
Assessed by echocardiography
30 days, 90 days, 180 days and once annually for five years
Patient success
Time Frame: 1 year
Per MVARC Criteria
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shockwave Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

August 6, 2024

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimated)

February 1, 2017

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 047-CPT-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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