Real World Data Collection on the INSPIRIS RESILIA Aortic Valve (NCT07120048) | Clinical Trial Compass
RecruitingNot Applicable
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Germany500 participantsStarted 2025-07-30
Plain-language summary
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
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
. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
. Age ≥ 18 years
. Provision of written informed consent
Exclusion criteria
. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
. Emergency procedure
. Patients requiring a non-aortic heart valve procedure during the index procedure
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.
What they're measuring
1
Subject's average mean gradient measurement over time
Timeframe: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
2
Subject's average peak gradient measurement over time
Timeframe: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
3
Amount of aortic transvalvular regurgitation in subjects over time
Timeframe: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
4
Amount of aortic paravalvular regurgitation in subjects over time
Timeframe: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months