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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitätsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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