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

NCT ID NCT03339115

Ongoing Disease control Sponsor: Cardiovalve Ltd. Source: ClinicalTrials.gov ↗

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

Summary

This study tests a new device called the Cardiovalve, which is threaded through a blood vessel in the leg to fix a leaky mitral valve without open-heart surgery. It includes 30 people with severe mitral regurgitation who are too high-risk for traditional surgery. The goal is to see if the device is safe and can reduce the backward flow of blood, improving symptoms and quality of life over two years.

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Conditions

The condition(s) this trial relates to.

heart disorder heart failure heart valve disorder mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

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

MITRAL REGURGITATION MITRAL VALVE DISEASE

Contacts and locations

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Locations

A.O.U. Pisana

Pisa, 56126, Italy
Fondazione Toscana G. Monasterio-Ospedale del Cuore

Massa, 54100, Italy
Herzzentrum der Uniklinik Köln

Cologne, Germany
Hygea

Athens, Greece
Klinikum der Universität München LMU

München, Germany
Maria Cecilia Hospital

Cotignola, Italy
Policlinico San Donato

Milan, Italy
San Raffaele Hospital

Milan, 20129, Italy
Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck

Lübeck, Germany
Universitaet_Mainz

Mainz, Germany
Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

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