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Colibri Transcatheter Aortic Heart Valve System Study

NCT04029844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-21

No results posted yet for this study

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

  • Severe Aortic Stenosis

Interventions

DEVICE

Colibri TAVI System

Implantation of Colibri heart valve

Sponsors & Collaborators

  • Colibri Heart Valve LLC

    lead INDUSTRY

Principal Investigators

  • Bernard Chevalier, MD · Hopital Prive Jacques Cartier

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029844 on ClinicalTrials.gov