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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
Led by Colibri Heart Valve LLC · Updated on 2023-02-21
30
Participants Needed
5
Research Sites
261 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the Colibri Transcatheter Aortic Heart Valve System in patients aged over 75 years who have symptomatic severe aortic stenosis and are at high surgical risk. This prospective, single-arm clinical investigation will be conducted at about seven European sites to assess the safety and performance of this heart valve system compared to recent historical results. The primary focus is on the rate of all-cause mortality at 30 days post-implantation, with additional evaluations up to five years after the procedure. Participants will receive the Colibri heart valve implanted via transfemoral access. This treatment is intended for patients with severe aortic tricuspid valve stenosis who meet specific anatomical and clinical criteria, such as heart valve measurements and surgical risk assessments. The study involves a single treatment group receiving the investigational device, with follow-up visits scheduled at 30 days, 6 months, 12 months, and annually up to five years to monitor the device's performance and safety. During the study, participants will undergo assessments including ECG-gated Multi-Slice Computed Tomography (MSCT) for valve measurements and clinical evaluations by the Heart Team and a Centralized Case Review Committee. Researchers will track mortality and adverse events, along with heart function and symptom status. Participants are expected to provide informed consent and agree to scheduled follow-ups to help researchers understand the device's long-term impact on patient health and safety.
CONDITIONS
Brief Title
Colibri Transcatheter Aortic Heart Valve System Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 75 years
- Severe aortic tricuspid valve stenosis with high-gradient aortic stenosis (mean pressure gradient > 40 mmHg or peak velocity > 4.0 m/s)
- Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class greater than II
- Local Heart Team agreement of high surgical risk
- Aortic annulus measurement between 22 mm and 27.4 mm by ECG-gated Multi-Slice Computed Tomography (MSCT)
- Eligibility confirmed by a TAVI Centralized Case Review Committee
- Ability to understand the study purpose, provide informed consent, and agree to follow-up requirements
You will not qualify if you...
- Arterial aorto-iliac-femoral axis unsuitable for transfemoral access
- Aortic root anatomy preventing valve implantation or access
- Non-calcific acquired aortic stenosis
- Native unicuspid/bicuspid or congenital aortic valve abnormality
- Previous heart valve implantation
- Severe aortic, mitral, or tricuspid regurgitation (> 3+)
- Severe left ventricular dysfunction (LVEF < 30%)
- Presence of intracardiac mass, thrombus, or vegetation
- Multi-vessel coronary artery disease with high Syntax Score
- Cardiogenic shock
- Untreated cardiac conduction disease needing pacemaker
- Uncontrolled atrial fibrillation (resting heart rate > 120 bpm)
- Active or suspected endocarditis or sepsis
- Blood disorders such as leukopenia, thrombocytopenia, bleeding diathesis, 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 treatment
- Active bleeding preventing anticoagulation
- Liver failure (Child-C)
- End-stage renal disease requiring dialysis or low creatinine clearance
- Pulmonary hypertension (systolic pressure > 80 mmHg)
- Severe chronic obstructive pulmonary disease (FEV1 < 750 cc)
- Refusal of blood transfusion
- Hypersensitivity or contraindications to anticoagulation, device materials, or contrast media
- Medical, social, or psychological conditions precluding consent or follow-up
- Participation in another ongoing drug or device trial
- Life expectancy less than 12 months
- Pregnancy or intention to become pregnant (for females)
- Inability to comply with study requirements
- Subject under judicial protection, tutorship, or curatorship (France only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the implantation of the Colibri Transcatheter Aortic Heart Valve System via transfemoral access.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for safety and performance of the implanted valve, including assessment of all-cause mortality and other outcomes.
Approximately 2 follow-up visits (in-person)
Trial Site Locations
Total: 5 locations
1
Institut Coeur Poumon, CHRU
Lille, France
Actively Recruiting
2
Hôpital Privé Jacques Cartier
Massy, France, 91300
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3
Clinique Pasteur
Toulouse, France
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4
Brighton & Sussex University Hospital, Roayl Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
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5
Barts Heart Centre / St Bartholomew's Hospital
London, United Kingdom, EC1A7E
Actively Recruiting
Research Team
R
R David Fish, MD
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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