Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE) (NCT04797572) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Belgium120 participantsStarted 2021-03-22
Plain-language summary
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to assess aortic valve function.
Who can participate
Age range
18 Years – 80 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 with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Exclusion Criteria:
* Acute aortic dissection;
* Diffuse aortic valve calcification;
* AV endocarditis;
* Bicuspid, unicuspid or quadricuspid aortic valves;
* Patients under the age of 18 years;
* Patients above the age of 80 years.
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
Intraoperative aortic valve (AV) damage
Timeframe: 30 days
2
Hospital mortality
Timeframe: 30 days
3
Major adverse cardiac and cerebrovascular events (MACCE)
Timeframe: one year
4
Aortic valve function
Timeframe: One year
Trial details
NCT IDNCT04797572
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain