Colibri Transcatheter Aortic Heart Valve System for severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

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• RENATUS transcatheter aortic valve for severe aortic stenosis

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• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

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• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

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• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.