Actively Recruiting
Colibri Transcatheter Aortic Heart Valve System Study
Led by Colibri Heart Valve LLC · Updated on 2023-02-21
30
Participants Needed
5
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Colibri Transcatheter Aortic Heart Valve System Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject older than 75 years
- Severe aortic tricuspid valve stenosis with mean pressure gradient > 40 mmHg or peak velocity > 4.0 m/s
- Symptomatic aortic valve stenosis with NYHA Class greater than II
- Local Heart Team agreement of high surgical risk
- Aortic annulus size between 22 mm and 27.4 mm by ECG-gated MSCT
- Eligibility confirmed by TAVI Centralized Case Review Committee
- Ability to understand the study purpose, provide informed consent, and comply with follow-up
You will not qualify if you...
- Unsuitable arterial access for transfemoral procedure due to vessel size or anatomy
- Aortic root anatomy preventing valve implantation or access
- Non-calcific acquired aortic stenosis
- Native unicuspid or bicuspid aortic valve or congenital valve abnormalities
- Previous heart valve implantation in any position
- Severe aortic, mitral, or tricuspid regurgitation greater than grade 3+
- Severe left ventricular dysfunction with ejection fraction less than 30%
- Presence of intracardiac mass, thrombus, or vegetation
- Multi-vessel coronary artery disease with high Syntax Score or unprotected left main artery
- Cardiogenic shock
- Untreated cardiac conduction disease requiring pacemaker
- Uncontrolled atrial fibrillation with resting heart rate over 120 bpm
- Active or suspected endocarditis or ongoing sepsis
- Blood disorders such as leukopenia, thrombocytopenia, bleeding disorders, or hypercoagulable states
- Recent acute myocardial infarction within 30 days
- Need for emergency surgery
- Recent cerebrovascular accident or transient ischemic attack within 6 months
- Symptomatic carotid or vertebral artery disease or recent carotid treatment within 30 days
- Active bleeding that prevents anticoagulation
- Liver failure classified as Child-C
- End-stage renal disease requiring dialysis or creatinine clearance below 20 cc/min
- Pulmonary hypertension with systolic pressure above 80 mmHg
- Severe chronic obstructive pulmonary disease with FEV1 less than 750 cc
- Refusal of blood transfusion
- Known allergy or contraindication to anticoagulation, cobalt chromium, porcine/collagen, glutaraldehyde, or contrast media
- Any medical, social, or psychological condition preventing consent or follow-up
- Participation in another drug or device trial with unassessed primary endpoint
- Life expectancy less than 12 months
- Pregnancy or intention to become pregnant before study completion
- Inability to comply with study requirements
- Subject under judicial protection, tutorship, or curatorship (France only)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Institut Coeur Poumon, CHRU
Lille, France
Actively Recruiting
2
Hôpital Privé Jacques Cartier
Massy, France, 91300
Actively Recruiting
3
Clinique Pasteur
Toulouse, France
Actively Recruiting
4
Brighton & Sussex University Hospital, Roayl Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Actively Recruiting
5
Barts Heart Centre / St Bartholomew's Hospital
London, United Kingdom, EC1A7E
Actively Recruiting
Research Team
R
R David Fish, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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