CompletedNot Applicable

Tiara™ Transcatheter Mitral Valve Replacement Study

Germany, Israel, Italy157 participantsStarted 2017-03-08

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from all-cause mortality

Timeframe: 30 days

Freedom from major adverse events

Timeframe: 30 Days

Reduction of Mitral Regurgitation to optimal or acceptable

Timeframe: 30 days

Trial details

NCT IDNCT03039855

SponsorShockwave Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-19

View on ClinicalTrials.gov More Mitral Valve Regurgitation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.