Colibri Transcatheter Aortic Heart Valve System for severe aortic stenosis
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
This study is testing a new heart valve system to see if it can safely help older patients with severe aortic stenosis who are at high risk for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Colibri Heart Valve LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Lille and 4 other locations) |
| Trial ID | NCT04029844 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety and performance of the Colibri Transcatheter Aortic Heart Valve System in treating symptomatic severe aortic stenosis in high surgical risk patients. Conducted at approximately seven sites across Europe, the study aims to enroll 30 subjects aged over 75 years who meet specific criteria for high surgical risk. The primary objective is to assess all-cause mortality at 30 days post-implantation, comparing results to recent historical data. The study utilizes transfemoral access for valve implantation.
Who should consider this trial
Good fit: Ideal candidates are patients over 75 years old with symptomatic severe aortic tricuspid valve stenosis and deemed high surgical risk.
Not a fit: Patients with unsuitable arterial access for transfemoral procedures or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for high-risk patients suffering from severe aortic stenosis.
How similar studies have performed: Other studies have shown success with transcatheter aortic valve implantation approaches, indicating potential for this method as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 sheath introducer) * 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 glutaraldehyde or contrast media * 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)
Where this trial is running
Lille and 4 other locations
- Institut Coeur Poumon, CHRU — Lille, France (Recruiting)
- Hôpital Privé Jacques Cartier — Massy, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Brighton & Sussex University Hospital, Roayl Sussex County Hospital — Brighton, East Sussex, United Kingdom (Recruiting)
- Barts Heart Centre / St Bartholomew's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Bernard Chevalier, MD — Hopital Prive Jacques Cartier
- Study coordinator: R David Fish, MD
- Email: colibriTAVI@colibrihv.com
- Phone: 1 (303) 460 8667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.