VALVOSOFT® Pivotal Study (NCT05235568) | Clinical Trial Compass
CompletedNot Applicable
VALVOSOFT® Pivotal Study
France, Germany, Netherlands60 participantsStarted 2022-06-15
Plain-language summary
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
. Age ≥18 years; and
. Subject willing to provide a written informed consent prior to participating in the study; and
. Subject who can comply with the study follow-up or other study requirements; and
. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).
Exclusion criteria
. Subject with severe aortic regurgitation; or
. Subject with unstable arrhythmia not controlled by medical treatment; or
. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.