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Status:

RECRUITING

Colibri Transcatheter Aortic Heart Valve System Study

Lead Sponsor:

Colibri Heart Valve LLC

Conditions:

Severe Aortic Stenosis

Eligibility:

All Genders

75+ years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

September 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2028

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04029844

Start Date

September 15 2021

End Date

July 1 2028

Last Update

February 21 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Institut Coeur Poumon, CHRU

Lille, France

2

Hôpital Privé Jacques Cartier

Massy, France, 91300

3

Clinique Pasteur

Toulouse, France

4

Brighton & Sussex University Hospital, Roayl Sussex County Hospital

Brighton, East Sussex, United Kingdom, BN2 5BE