Mitral Valve RegurgitationTIARA-INCT02276547
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
A study testing Mitral valve replacement in people with Mitral Valve Regurgitation, run by Shockwave Medical, Inc. at 10 sites in 3 countries.
Trial summary
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. 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?
- Mitral valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 5 Feb 2015to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
Who cannot join
- DMR deemed by the heart team to be operable.
- Prohibitive risk, deemed too frail or listed for cardiac transplant.
- Unsuitable cardiac structure
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States6 sites
Northwestern University
Chicago, Illinois, 60611
Henry Ford Health System
Detroit, Michigan, 48188
Cedars Sinai Medical Center
Los Angeles, California, 90048
Columbia University Medical Center
New York, New York, 10032
University of Washington Medical Center
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
London Health Sciences Centre
London, Ontario, N6A 5A5
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery 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.
Read the detailed description
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.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Mitral valve replacement
- Keywords
- Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
- 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.
Mitral valve replacementDevice
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: Mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From All-cause Mortality and Major Adverse Events
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Measured: From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)
Secondary outcomes (8)
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
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
Measured: 30 days, 90 days, 180 days and annually to five years
Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events
- 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
Measured: 30 days
Number and Percentage of Subjects With Progression of Heart Failure
Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
Measured: One year
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
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
Measured: Post procedure
Days Alive and Out of Hospital
Number of subjects alive and not hospitalized
Measured: At one year
Performance - KCCQ
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.
Measured: 30 days, 90 days, 180 days and annually for five years
Performance - NYHA
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.
Measured: 30 days, 90 days, 180 days and annually for five years
Performance - 6MWT
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.
Measured: 30 days, 90 days, 180 days and annually for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start5 Feb 2015
- Primary completion6 Jan 2020
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anson Cheung, MD, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276547
- Sponsor's protocol ID
- 047-CPT-001
- Acronym
- TIARA-I
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2014
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
PubMed 24944303Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
PubMed 24939033Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
PubMed 23084102
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
- ClinicalTrials.gov ID
- NCT02276547
- Acronym / sponsor ID
- TIARA-I / 047-CPT-001
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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: Mitral valve replacementTranscatheter 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 (4 listed)
- 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
Key exclusion criteria (3 listed)
- DMR deemed by the heart team to be operable.
- Prohibitive risk, deemed too frail or listed for cardiac transplant.
- Unsuitable cardiac structure
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 |
|---|---|---|
| Mitral valve replacementAlso: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery SystemTranscatheter mitral valve replacement | Device | Treatment |
Primary outcome
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
8 secondary outcomes
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
Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events
Time frame: 30 days
Number and Percentage of Subjects With Progression of Heart Failure
Time frame: One year
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
Time frame: Post procedure
Days Alive and Out of Hospital
Time frame: At one year
Performance - KCCQ
Time frame: 30 days, 90 days, 180 days and annually for five years
Performance - NYHA
Time frame: 30 days, 90 days, 180 days and annually for five years
Performance - 6MWT
Time frame: 30 days, 90 days, 180 days and annually for five years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24944303De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
- Background: PubMed 24939033Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
- Background: PubMed 23084102Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
- Company website with product informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
Anson Cheung, MD study chair
University of British Columbia
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve replacement in people with Mitral Valve Regurgitation, run by Shockwave Medical, Inc. at 10 sites in 3 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 4 inclusion and 3 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Belgium. 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?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276547, which also lists 3 linked publications.
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 24 Jul 2026.