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New heart valve fix without open surgery shows promise in High-Risk patients

NCT ID NCT03039855

Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the Tiara valve, which is implanted through a small tube in the chest to replace the leaky mitral valve without open-heart surgery. It enrolled 157 people with severe mitral regurgitation who were considered too high-risk for traditional surgery. The main goals were to see if the device could safely reduce the valve leakage and improve survival and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tiara mitral valve and delivery system (a device implanted via a tube through the chest to replace the leaky heart valve)
What this could lead to
If it works, this could offer a less invasive option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This is a completed early-stage study without a control group, so results may not apply to all patients. Device implantation carries risks like bleeding, infection, or valve failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

157 people

The number who actually took part.

Started

Mar 2017

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mitral valve regurgitation

Contacts and locations

Locations

  • Deutches Herzzentrum Berlin

    Berlin, 13353, Germany

  • Edinburgh Heart Centre Royal Infirmary

    Edinburgh, EH16 4SA, United Kingdom

  • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.

    Roma, RM, 00168, Italy

  • Fondazione Toscana 'Gabriele Monasterio'

    Massa, 54100, Italy

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545, Germany

  • Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg

    Rotenburg an der Fulda, Germany

  • Herzzentrum Leipzig

    Leipzig, 04289, Germany

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097, Italy

  • Immanuel Klinikum Bernau und Herzzentrum Brandenburg

    Bernau, 16321, Germany

  • Kerckhoff Klinik Herzzentrum-Herzchirurgie

    Bad Nauheim, 61231, Germany

  • King's College Hospital

    London, SE59RS, United Kingdom

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Sana Herzchirurgie Stuttgart GmbH

    Stuttgart, 70174, Germany

  • Schüchtermann-Klinik

    Bad Rothenfelde, 49214, Germany

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • St.-Johannes-Hospital, Klinik für Innere Medizin I

    Dortmund, 44229, Germany

  • Tel Aviv Medical Center

    Tel Aviv, Israel

  • Universitasklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

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