Mitral Valve RegurgitationTIARA-IINCT03039855
Tiara™ Transcatheter Mitral Valve Replacement Study
A study testing TIARA valve and transapical delivery system in people with Mitral Valve Regurgitation, run by Shockwave Medical, Inc. at 20 sites in 6 countries.
Trial summary
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- TIARA valve and transapical delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 8 Mar 2017to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe mitral regurgitation
- High surgical risk for open mitral valve surgery
- Subject meets anatomical eligibility criteria
Who cannot join
- 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
Show all 9Show fewer
- Documented bleeding or coagulation disorders
- Active infections requiring antibiotic therapy
- Subjects with a life expectancy less than 12 months
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Germany11 sites
Kerckhoff Klinik Herzzentrum-Herzchirurgie
Bad Nauheim, 61231
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Schüchtermann-Klinik
Bad Rothenfelde, 49214
Deutches Herzzentrum Berlin
Berlin, 13353
Immanuel Klinikum Bernau und Herzzentrum Brandenburg
Bernau, 16321
St.-Johannes-Hospital, Klinik für Innere Medizin I
Dortmund, 44229
Universitätsklinikum Halle
Halle, 06120
Universitasklinikum Hamburg-Eppendorf
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, 04289
Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
Rotenburg an der Fulda
Sana Herzchirurgie Stuttgart GmbH
Stuttgart, 70174
Italy4 sites
Fondazione Toscana 'Gabriele Monasterio'
Massa, 54100
Ospedale San Raffaele
Milan, 20132
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
Roma, RM, 00168
IRCCS Policlinico San Donato
San Donato Milanese, 20097
United Kingdom2 sites
Edinburgh Heart Centre Royal Infirmary
Edinburgh, EH16 4SA
King's College Hospital
London, SE59RS
About this study
Official title: 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.
Read the detailed description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- TIARA valve and transapical delivery system
- Keywords
- Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR
- Medical subject headings
- Mitral Valve Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIARA valve and transapical delivery systemDevice
Also called TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System
Transcatheter mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system Receives: Device: TIARA valve and transapical delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality
Measured: 30 days
Freedom from major adverse events
Measured: 30 Days
Reduction of Mitral Regurgitation to optimal or acceptable
Measured: 30 days
Secondary outcomes (10)
Freedom from all-cause mortality
Measured: 90 days, 180 days, one year and annually to five years
Freedom from major adverse events
Measured: 90 days, 180 days, one year and annually to five years
Technical success
Per MVARC criteria
Measured: Day 0
Procedural success
Per MVARC criteria
Measured: 30 days
Device success
Per MVARC criteria
Measured: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
NYHA Functional Class
Number of subjects with improved NYHA class
Measured: 30 days, 90 days, 180 days and once annually for five years
6 Minute Walk Test
Increase in distance (m) from baseline
Measured: 30 days, 90 days, 180 days and once annually for five years
Kansas City Cardiomyopathy Questionnaire
Improvement in quality of life
Measured: 30 days, 90 days, 180 days and once annually for five years
Hemodynamic performance
Assessed by echocardiography
Measured: 30 days, 90 days, 180 days and once annually for five years
Patient success
Per MVARC Criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start8 Mar 2017
- Primary completion19 Dec 2019
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039855
- Sponsor's protocol ID
- 047-CPT-003
- Acronym
- TIARA-II
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2017
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
- ClinicalTrials.gov ID
- NCT03039855
- Acronym / sponsor ID
- TIARA-II / 047-CPT-003
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TIARA valve and transapical delivery systemTranscatheter mitral valve replacement with the TIARA valve and transapical delivery system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe mitral regurgitation
- High surgical risk for open mitral valve surgery
- Subject meets anatomical eligibility criteria
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIARA valve and transapical delivery systemAlso: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery SystemTranscatheter mitral valve replacement | Device | Treatment |
Primary outcome
Freedom from all-cause mortality
Time frame: 30 days
Freedom from major adverse events
Time frame: 30 Days
Reduction of Mitral Regurgitation to optimal or acceptable
Time frame: 30 days
10 secondary outcomes
Freedom from all-cause mortality
Time frame: 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
Technical success
Time frame: Day 0
Procedural success
Time frame: 30 days
Device success
Time frame: 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
6 Minute Walk Test
Time frame: 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
Hemodynamic performance
Time frame: 30 days, 90 days, 180 days and once annually for five years
Patient success
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Company website with product informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIARA valve and transapical delivery system in people with Mitral Valve Regurgitation, run by Shockwave Medical, Inc. at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Italy, United Kingdom, Israel, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from all-cause mortality (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.