Georges Pompidou European Hospital (HEGP, AP-HP) in Paris, France and the Amphia Hospital in Breda, Netherlands completed an international trial involving ten patients in the study of Cardiawave’s Valvosoft device, a non-invasive treatment of calcified aortic stenosis.  1.3 million have this condition in Europe. Results were reported at the TCT conference in the United States.

What is Calcified Aortic Stenosis?

This involves the narrowing of the exist of the left ventricle of the heart (where the aorta begins), such that problems result. It may occur at the aortic valve as well as above and below this level. It typically worsens over time. Symptoms come on gradually with a decreased ability to exercise often occurring first. If heart failure, loss of consciousness, or heart related chest pain occur due to this ailment the outcomes are worse. Loss of consciousness typically occurs with standing or exercise.

In calcific aortic stenosis at least the calcification in and around the aortic valve can progress and extend to involve the electrical conduction system of the heart. If that occurs, the result may be heart block, a potentially deadly condition of which syncope may be a symptom.

The Study

The study is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft Pulsed Cavitational Ultrasound Therapy (PCUT)—First-in-Man in 10 patients. The clinical sites included hospitals in France and the Netherlands.

The patients participating in this study weren’t eligible for percutaneous aortic valve replacement (TAVR) nor for open-heart surgery, mainly due to the presence of concomitant disease or due to difficulties in accessing the blood vessels with a catheter. Therefore, like 16% of people affected by severe aortic valve calcification (1.3 million people in Europe), they were left with no alternative treatment.

The Investigational Product

CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE’s Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve’s tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. This is a FIM study

The Results

The study team reports that the analysis of the post-operative echocardiographic data, performed buy an independent centralized laboratory and factoring in the clinical results at 30 days confirm that the primary objectives—establishing the safety and feasibility of this procedure—have been met.

Lead Research/Investigator

Hospital European Georges Pompidou, France

Amphia Hospital, Netherlands

Cardiawave SA

The sponsor of the study is sponsored by Cardiawave SA. Formed at the end of 2014 as a result of a 6 year partnership between the Langevin Institute/Physics for Medicine Paris, a world leader in ultrasound imaging and therapy, and the Georges Pompidou European Hospital (HEGP), a leader in the field of valve disease and cardiac ultrasound imaging.

Call to Action: Interested in learning more? A second trial in 10 patients will be conducted in collaboration with the Belgrade University Hospital Center (Serbia) in early 2020. The goal of this trial is to further confirm the safety of the treatment. A more extensive study has already been scheduled for the end of 2020, as part of the process to obtain the CE marking and enter the European market.

Source: Cath Lab Digest

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