Trials / Recruiting
RecruitingNCT04029844
Colibri Transcatheter Aortic Heart Valve System Study
A Prospective, Single Arm Clinical Investigation Evaluating 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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Colibri Heart Valve LLC · Industry
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Colibri TAVI System | Implantation of Colibri heart valve |
Timeline
- Start date
- 2021-09-15
- Primary completion
- 2023-07-01
- Completion
- 2028-07-01
- First posted
- 2019-07-23
- Last updated
- 2023-02-21
Locations
5 sites across 2 countries: France, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04029844. Inclusion in this directory is not an endorsement.