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New treatment option for Severe Aortic Stenosis
Official title Colibri Transcatheter Aortic Heart Valve System Study
ClinicalTrials.gov ID: NCT04029844
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- 1\. Subject of age \> 75 years
- 2\. Subject suffering from severe aortic tricuspid valve stenosis defined as follows: High-gradient aortic stenosis (mean pressure gradient across...
- 3\. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) \> Class II
- 4\. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population
- 5\. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus \> 22 mm and \< 27.4 mm
You likely can't join if
- 1\. Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multidetector computed...
- 2\. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
- 3\. Non-calcific acquired aortic stenosis
- 4\. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
- 5\. Previous implantation of heart valve in any position
- 6\. Severe aortic regurgitation (\> 3+)
See the full eligibility criteria
Who can join
- 1\. Subject of age \> 75 years
- 2\. 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)
- 3\. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) \> Class II
- 4\. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population
- 5\. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus \> 22 mm and \< 27.4 mm
- 6\. Subject deemed eligible by a TAVI Centralized Case Review Committee (CRC)
- 7\. 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
What rules you out
- 1\. 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...
- 2\. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
- 3\. Non-calcific acquired aortic stenosis
- 4\. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
- 5\. Previous implantation of heart valve in any position
- 6\. Severe aortic regurgitation (\> 3+)
- 7\. Severe mitral regurgitation (\> 3+)
- 8\. Severe tricuspid regurgitation (\> 3+)
- 9\. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \< 30%)
- 10\. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- 11\. Multi-vessel coronary artery disease (CAD) with a Syntax Score or residual Syntax Score \> 22 and/or unprotected left main coronary artery
- 12\. Cardiogenic shock
- 13\. Untreated cardiac conduction disease in need of pacemaker implantation
- 14\. Uncontrolled atrial fibrillation (resting heart rate (HR) \> 120bpm)
- 15\. Active and/or suspicion of endocarditis or ongoing sepsis
- 16\. Blood dyscrasias defined as: leukopenia (White Blood Cells (WBC) \< 1,000/mm3), thrombocytopenia (Platelets (PLT) \< 50,000/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- 17\. Evidence of acute myocardial infarction (MI) less than 30 days before signing informed consent
- 18\. Any need for emergency surgery
- 19\. Recent (\< 6 months of signing informed consent) CerebroVascular Accident (CVA) or Transient Ischemic Attack (TIA)
- 20\. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis \< 30 days prior to signing informed consent
- 21\. Any active bleeding that precludes anticoagulation
- 22\. Liver failure (Child-C)
- 23\. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20cc/min
- 24\. Pulmonary hypertension (systolic pressure \>80mmHg)
- 25\. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by a Forced Expiratory Volume (FEV1) \< 750cc
- 26\. Refusal of blood transfusion
- 27\. A known hypersensitivity or contraindication to all anticoagulation/anti-platelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to porcine and/or collagen, to...
- 28\. Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures
- 29\. Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed
- 30\. Estimated life expectancy of less than 12 months
- 31\. For females, pregnancy or intention to become pregnant prior to completion of all follow-up procedures
- 32\. Inability to comply with the clinical investigation requirements
- 33\. Subject under judicial protection, tutorship or curatorship (for France only)
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
- Massy, France
- Toulouse, France
- Brighton, East Sussex, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France; Massy, France; Toulouse, France; Brighton, East Sussex, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.