Aortic Valve Stenosis Clinical Trial Data Reported in The Lancet


Key Points

  • Cardiawave SA has published six-month clinical data from its ongoing, first-in-human Valvosoft® studies to treat severe symptomatic calcific aortic valve stenosis.
  • The device delivers focused ultrasound to calcified aortic valves to soften the valve leaflets and improve function.
Calcific aortic stenosis before and after treatment.

Treatment of Severe Symptomatic Aortic Valve Stenosis Using Non-Invasive Ultrasound Therapy: A Cohort Study

French medtech company Cardiawave SA recently announced publication in a prestigious journal, The Lancet, of new clinical data. Its prospective, single-arm, multi-site first-in-human (FIH) studies (Valvosoft® FIM study) are using noninvasive ultrasound therapy (NIUT) to treat severe symptomatic calcific aortic stenosis. The device delivers focused ultrasound to calcified aortic valves to soften the valve leaflets and improve valve function.

Six-month follow-up data from 40 participants in the FIH studies (NCT03779620 and NCT04665596) are now available. The study’s primary endpoints are procedure-related deaths within 30 days and improved valve function. These primary endpoints were met in the six-month data, as participants had no procedure-related mortality through 30 days, improved valve function demonstrated by a 10% increase in mean aortic valve area, a 7% decrease in mean pressure gradient, and improved quality-of-life measurements.

“This study was done in Europe,” said Tim Meakem, MD, the Foundation’s Chief Medical Officer. “Beyond establishing the safety of the procedure, the treatment group had improvement in aortic valve opening, with only one temporary but serious side effect not linked to the therapy (decreased peripheral oxygen saturation, likely caused by sedation).”

The participants, who had multiple co-morbidities and a mean Society of Thoracic Surgeons score of 5.6%, showed improvements in their New York Heart Association scores and Kansas City Cardiomyopathy Questionnaires.

The three treating hospitals were in Paris, France (Hôpital Européen Georges Pompidou, AP-HP), Breda, the Netherlands (Amphia Hospital), and Belgrade, Serbia (University Clinical Center of Serbia). The coordinating investigator is cardiologist Prof. Emmanuel Messas, MD, PhD, FESC, at Hôpital Européen Georges Pompidou AP-HP in Paris.

In Cardiawave’s press release, Professor Roxana Mehran, MD, PhD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, a cardiologist at Mount Sinai who is a member of Cardiawave’s scientific advisory board, said, “Results from this FIH series with a cohort of very frail patients suggest that the use of NIUT is feasible and safe, and efficient with statistically significant improvements of hemodynamic and clinical parameters in high-risk patients with calcific aortic stenosis (CAS). Clinically, the patients experienced a considerable improvement in their clinical status suggesting a better quality of life. These early findings can represent a change in the paradigm of CAS treatment especially for patients who have no other options. I am encouraged by the momentum of these study results as I anticipate that this therapy potentially brings a new medical breakthrough to many patients suffering from CAS in the world.”

As of July 2023, the ongoing pivotal study (“Valvosoft® Pivotal Study” – NCT 05235568) has completed enrollment of 60 participants at 11 clinical sites in France, Germany, and the Netherlands. Therefore, additional data will be forthcoming.

The study is being funded by Cardiawave AS, and the company is preparing a Series B financing round to enable scaling up market access in Europe and launching United States trials and US Food and Drug Administration pre-market approval. Valvosoft is an investigational device exclusively for clinical investigations.

See The Lancet

Read Cardiawave’s Press Release

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