Colibri Transcatheter Aortic Heart Valve System Study (NCT04029844) | Clinical Trial Compass
RecruitingNot Applicable
Colibri Transcatheter Aortic Heart Valve System Study
France, United Kingdom30 participantsStarted 2021-09-15
Plain-language summary
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This study will be conducted in about 7 European sites. The study will evaluate the safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients.
30 subjects suffering from symptomatic severe aortic tricuspid valve stenosis and who are at high surgical risk (logistic EuroSCORE I \> 20% or other risk factors not included in this score such as frailty, porcelain aorta, sequelae of chest radiation or logistic EuroSCORE I \< 20% but considered at high risk by local Heart Team evaluation) will be enrolled in this clinical investigation.
The primary objective of this clinical investigation is to evaluate the all-cause mortality at 30 days post implantation. The secondary objectives are to evaluate the safety and performance of the investigational device at 30 days, 6 and 12 months, and 2, 3, 4, 5 years post implantation.
Who can participate
Age range
75 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:
* 1\. Subject of age \> 75 years
* 2\. Subject suffering from severe aortic tricuspid valve stenosis defined as follows: High-gradient aortic stenosis (mean pressure gradient across aortic valve \> 40 mmHg or peak velocity \> 4.0 m/s)
* 3\. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) \> Class II
* 4\. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population
* 5\. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus \> 22 mm and \< 27.4 mm
* 6\. Subject deemed eligible by a TAVI Centralized Case Review Committee (CRC)
* 7\. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements
Exclusion Criteria:
* 1\. Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multidetector computed tomographic angiography (access vessel diameter incompatible with a 16F sheath introducer)
* 2\. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
* 3\. Non-calcific acquired aortic stenosis
* 4\. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
* 5\. Previous implantation of heart valve in any position
* 6\. Severe aortic regurgitation (\> 3+)
* 7\. Severe mitral regurgitation (\> 3+)
* 8\. Severe tri…
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
Rate of all-cause mortality at 30 days post implantation