Colibri Transcatheter Aortic Heart Valve System Study

NCT04029844 | Recruiting FDA Device

• 1 other identifier: COL-01
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of all-cause mortality at 30 days post implantation

  30 Days

Study Arms (1)

Colibri Device

EXPERIMENTAL

Treatment

Device: Colibri TAVI System

Interventions

Colibri TAVI System DEVICE

Implantation of Colibri heart valve

Colibri Device

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. Subject of age \> 75 years
• \. 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)
• \. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) \> Class II
• \. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population
• \. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus \> 22 mm and \< 27.4 mm
• \. Subject deemed eligible by a TAVI Centralized Case Review Committee (CRC)
• \. 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

You may not qualify if:

• \. 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)
• \. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
• \. Non-calcific acquired aortic stenosis
• \. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
• \. Previous implantation of heart valve in any position
• \. Severe aortic regurgitation (\> 3+)
• \. Severe mitral regurgitation (\> 3+)
• \. Severe tricuspid regurgitation (\> 3+)
• \. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \< 30%)
• \. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• \. Multi-vessel coronary artery disease (CAD) with a Syntax Score or residual Syntax Score \> 22 and/or unprotected left main coronary artery
• \. Cardiogenic shock
• \. Untreated cardiac conduction disease in need of pacemaker implantation
• \. Uncontrolled atrial fibrillation (resting heart rate (HR) \> 120bpm)
• \. Active and/or suspicion of endocarditis or ongoing sepsis

Sponsors & Collaborators

• Colibri Heart Valve LLC: lead

Study Sites (5)

Institut Coeur Poumon, CHRU

Lille, France

RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

Brighton & Sussex University Hospital, Roayl Sussex County Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

RECRUITING

Barts Heart Centre / St Bartholomew's Hospital

London, EC1A7E, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Bernard Chevalier, MD

  Hopital Prive Jacques Cartier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R David Fish, MD

CONTACT

1 (303) 460 8667; colibriTAVI@colibrihv.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: September 15, 2021
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

FR (3); GB (2)