Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy

New ultrasound therapy for severe aortic valve stenosis to be studied

NCT: NCT07520591 · Status: NOT YET RECRUITING · Phase: N/A · Sponsor: Cardiawave SA · Started: 2026-05-30 · Est. Completion: 2028-06-30

Plain English Summary

Valvosoft Outcomes Registry for Real-World Evidence is a Not Applicable clinical trial sponsored by Cardiawave SA studying Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure. This study will evaluate a new non-invasive ultrasound therapy called Valvosoft for severe symptomatic aortic valve stenosis. It is for patients with severe symptomatic aortic valve stenosis who are not recommended for or refuse standard valve replacement surgery. Participants will receive the Valvosoft treatment and be monitored for up to 12 months after the procedure. Alternative treatments include surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The trial aims to enroll 200 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with severe symptomatic calcific aortic stenosis. Patients who are not candidates for or refuse standard valve replacement surgery (TAVR/SAVR). Patients must be able to provide informed consent and attend follow-up appointments. Patients with a prosthetic aortic valve, chest deformities, or skin issues on the chest where the device is applied cannot participate. Pregnant or breastfeeding individuals are also excluded. This trial is studying Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will assess the safety of the Valvosoft treatment within 30 days after the procedure, meaning how well patients tolerate the therapy and if any immediate complications ari The specific primary outcome measures are: Safety Endpoint (at 30 days post procedure). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it explores a non-invasive ultrasound therapy as a potential new treatment option for patients with severe aortic valve stenosis who may not be suitable for or wish to This research targets Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure, where improved treatment options are needed.

Investor Insight

This registry aims to gather real-world data on a novel non-invasive ultrasound device for a significant cardiovascular condition, potentially opening a new market segment if proven effective and safe

Is This Trial Right for Me?

Ask your doctor if you are eligible and if this therapy is a good option for you compared to surgery. Understand that participation involves receiving the Valvosoft treatment and attending regular follow-up visits for a year. Be prepared for potential monitoring of your heart function and overall well-being throughout the study. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07520591?

NCT07520591 is a Not Applicable OBSERVATIONAL study titled "Valvosoft Outcomes Registry for Real-World Evidence." It is currently not yet recruiting and is sponsored by Cardiawave SA. The trial targets enrollment of 200 participants.

What conditions does NCT07520591 study?

This trial investigates treatments for Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure. The primary condition under study is Aortic Valve Disease.

What treatments are being tested in NCT07520591?

The interventions being studied include: Valvosoft Treatment (DEVICE). non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS

What does Not Applicable mean for NCT07520591?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07520591?

This trial is currently "Not Yet Recruiting." It started on 2026-05-30. The estimated completion date is 2028-06-30.

Who is sponsoring NCT07520591?

NCT07520591 is sponsored by Cardiawave SA. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07520591?

The trial aims to enroll 200 participants. The trial has not yet started recruiting.

How is NCT07520591 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07520591?

The primary outcome measures are: Safety Endpoint (at 30 days post procedure). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07520591 being conducted?

This trial is being conducted at 7 sites, including Lille; Paris; Rouen; Hamburg and 3 more sites (France, Germany, Netherlands).

Where can I find official information about NCT07520591?

The official record for NCT07520591 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07520591. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07520591 testing in simple terms?

This study will evaluate a new non-invasive ultrasound therapy called Valvosoft for severe symptomatic aortic valve stenosis. It is for patients with severe symptomatic aortic valve stenosis who are not recommended for or refuse standard valve replacement surgery.

Why is this trial significant?

This trial is important because it explores a non-invasive ultrasound therapy as a potential new treatment option for patients with severe aortic valve stenosis who may not be suitable for or wish to

What are the potential risks of participating in NCT07520591?

The main risks are related to the procedure itself and potential side effects from the ultrasound therapy, which will be closely monitored. Possible side effects could include discomfort at the treatment site or temporary changes in heart function, though the study aims to assess these thoroughly. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07520591?

Ask your doctor if you are eligible and if this therapy is a good option for you compared to surgery. Understand that participation involves receiving the Valvosoft treatment and attending regular follow-up visits for a year. Be prepared for potential monitoring of your heart function and overall well-being throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07520591 signal from an investment perspective?

This registry aims to gather real-world data on a novel non-invasive ultrasound device for a significant cardiovascular condition, potentially opening a new market segment if proven effective and safe This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive the Valvosoft treatment and be monitored for up to 12 months after the procedure. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.