Colibri Transcatheter Aortic Heart Valve System Study

ConditionSevere Aortic Stenosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age75+

SponsorColibri Heart Valve LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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