Aortic Stenosis, Severe, Aortic Valve Calcification, Aortic Valve Disease, Heart Failure, Ultrasound Therapy
Conditions
Brief summary
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS). Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue. This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.
Detailed description
Severe symptomatic calcific aortic stenosis is associated with high morbidity and mortality, and some patients are not eligible for or decline standard valve replacement therapies (TAVR/SAVR). Valvosoft® is an ultrasound image-guided, non-invasive therapy designed to mechanically soften calcified aortic valve leaflets using focused ultrasound energy without thermal damage. The VALOR-PMCF registry is a prospective, multicenter study conducted to confirm the safety, clinical performance, and benefit-risk profile of Valvosoft® in real-world practice following CE marking. Participants will be followed for up to 12 months to assess safety events, clinical status (NYHA), quality of life (KCCQ), and echocardiographic parameters, including aortic valve area and transvalvular gradients.
Interventions
DEVICEValvosoft Treatment
non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS
Sponsors
Cardiawave SA
T!Write
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease. 2. Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention. 3. Willing to provide a written informed consent prior to participating in this Registry. 4. Able to comply with the follow up schedule or other Study requirements.
Exclusion criteria
1. Prosthetic aortic valve; 2. Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator; 3. Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator; 4. Pregnant or breastfeeding Patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of MACE | at 30 days post procedure | Rate of MACE defined as a composite endpoint including all-cause mortality, myocardial infarction, stroke, myocardial infarction and rehospitalization for heart failure, up to 30-days post procedure(s) |
Countries
France, Germany, Netherlands
Contacts
CONTACTDirk Pauwels
CONTACTClemence PUPIER
PRINCIPAL_INVESTIGATORWon-Keun Kim
University Hospital Schleswig-Holstein
Outcome results
None listed