Prospective, Single-Arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using the Valvosoft Noninvasive Ultrasound Therapy

Q: What are the key findings of this study?

Noninvasive ultrasound therapy demonstrated an 8.3% rate for the 30-day primary safety composite endpoint in frail patients with severe calcific aortic stenosis, meeting the prespecified safety threshold.

Q: What is the clinical evidence from this study?

Population: Severe symptomatic calcific aortic valve stenosis (n=60). Intervention: Valvosoft Noninvasive Ultrasound Therapy (NIUT). Primary outcome: 30-day composite of all-cause mortality, myocardial infarction, coronary revascularization, stroke, major and life-threatening bleeding, and heart failure hospitalization (95% CI 2.8%-18.4%).

Q: What does this research mean for the field?

Noninvasive ultrasound therapy safely increases aortic valve area and improves functional status through 12 months in frail patients with severe calcific aortic stenosis ineligible for transcatheter aortic valve replacement. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.ESTABLISHES_NEW_DIRECTION.

Flavien Vincent; Hélène Eltchaninoff; Bernard Iung; Marleen van Wely; Étienne Puymirat; Menno van Gameren; Laurent Faroux; Giovanni Amoroso; Won‐Keun Kim; Éric Van Belle; Gaspard Suc; Osama Soliman; Bernard Cholley; Danijela Trifunović; Laurent Lepage; Dimitry Schewel; Alexander Ijsselmuiden; Mathieu Pernot; Mickaël Tanter; Christian Spaulding; Emmanuel Messas

doi:10.1161/circulationaha.125.077582

Key result

Noninvasive ultrasound therapy meets safety criteria with ~8% 30-day major adverse events in severe AS.

95% CI 2.8%-18.4%
n=60

Figures

Key Points

To assess the 12-month safety and clinical efficacy of Valvosoft noninvasive ultrasound therapy in patients with severe symptomatic calcific aortic stenosis who are ineligible for transcatheter aortic valve replacement.
Prospective, single-arm pivotal study conducted across 11 centers enrolling 60 patients (median age 88 years; 65% female) from June 2022 to July 2023.
Patients underwent noninvasive ultrasound therapy delivering focused ultrasound beams under real-time imaging guidance in sessions lasting up to 70 minutes to fracture leaflet calcifications via cavitation.
The primary safety endpoint (a 30-day composite of all-cause mortality, myocardial infarction, coronary revascularization, stroke, major/life-threatening bleeding, and heart failure hospitalization) occurred in 8.3% (95% CI, 2.8%–18.4%), remaining well below the 25% prespecified threshold.
The primary performance endpoint of New York Heart Association class improvement at 30 days occurred in 43% of patients, with 86% achieving improvement or stabilization.
Aortic valve area increased significantly from 0.67±0.22 cm2 at baseline to 0.81±0.24 cm2 at 12 months (P<0.001, n=24), with mean gradient changing from 37.0±12.6 to 34.3±11.6 mm Hg (P=0.096).

PICO

P

Population

60 frail patients (median age 88 years, 65% female) with severe calcified aortic stenosis ineligible for transcatheter aortic valve replacement, followed for up to 12 months.

I

Intervention / Comparator

Valvosoft Noninvasive Ultrasound Therapy (NIUT) (Up to 70 minutes of energy divided in cycles of 10 minutes maximum)

O

Primary Outcome

30-day composite of all-cause mortality, myocardial infarction, coronary revascularization, stroke, major and life-threatening bleeding, and heart failure hospitalization (2.8%-18.4%)

Limitations

Single-arm design
Small number of echocardiographic assessments due to the frail and comorbid population

Key expert perspectives

Captured external expert commentary on this paper, strongest first. Original sources are linked where available.

PC Prof. Christian SpauldingInterventional Cardiologist, Professor of Cardiology

“Aortic stenosis is progressive and threatens the lives of many millions of people each year. With the disease on the rise due to a rapidly aging population, new alternatives are needed for patients who cannot or do not want to undergo current valve replacement techniques. The Valvosoft technology holds the possibility to be an important and unique addition to our armamentarium to address progression of this deadly disease.”

European Hospital Georges Pompidou AP-HPDAIC

PE Prof. Emmanuel MessasInterventional Cardiologist

“Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated. Valvosoft® introduces a unique approach: restoring the mobility of the native valve without surgery or implantation. Clinical study results obtained in 100 patients confirm the feasibility, efficacy, and safety of this non-invasive therapy for patients who previously had no therapeutic option available.”

HEGP (AP-HP)

DPDr. Philippe GénéreuxInterventional Cardiologist and Director of the Structural Heart Program

“The CE Marking of Valvosoft confirms the clinical value of the approach: using therapeutic ultrasound to treat aortic stenosis in a non-invasive way. This important milestone is exciting and potentially marks the beginning of a new era in the management of valvular disease.”

Gagnon Cardiovascular Institute at Morristown Medical CenterDr. Philippe Généreux

Implication

Prospective single-arm trial demonstrates safety and hemodynamic improvement of noninvasive ultrasound therapy in inoperable aortic stenosis, indicating a viable noninvasive treatment option.

Abstract

Contains fulltext : 335071.pdf (Publisher’s version ) (Open Access)

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Cite This Study

Vincent et al. (2026) studied Severe symptomatic calcific aortic valve stenosis (n=60). Valvosoft Noninvasive Ultrasound Therapy (NIUT) was evaluated on 30-day composite of all-cause mortality, myocardial infarction, coronary revascularization, stroke, major and life-threatening bleeding, and heart failure hospitalization (95% CI 2.8%-18.4%). Noninvasive ultrasound therapy demonstrated an 8.3% rate for the 30-day primary safety composite endpoint in frail patients with severe calcific aortic stenosis, meeting the prespecified safety threshold.

synapsesocial.com/papers/6a7c3d5a06a85aed514b7ce5 https://doi.org/10.1161/circulationaha.125.077582

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Prospective, Single-Arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using the Valvosoft Noninvasive Ultrasound Therapy

Figures

Key Points

PICO

Limitations

Key expert perspectives

Implication

Abstract

Discussion

Cite This Study

Prospective, Single-Arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using the Valvosoft Noninvasive Ultrasound Therapy

Figures

Key Points

PICO

Limitations

Key expert perspectives

Implication

Abstract

Discussion

Cite This Study

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