Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Colibri Heart Valve LLC (Voir sur ClinicalTrials)
septembre 2021
juillet 2028
29 juin 2024
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. The study
will evaluate the 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.
30 subjects suffering from symptomatic severe aortic tricuspid valve stenosis and who are
at high surgical risk (logistic EuroSCORE I > 20% or other risk factors not included in
this score such as frailty, porcelain aorta, sequelae of chest radiation or logistic
EuroSCORE I < 20% but considered at high risk by local Heart Team evaluation) will be
enrolled in this clinical investigation.
The primary objective of this clinical investigation is to evaluate the all-cause
mortality at 30 days post implantation. The secondary objectives are to evaluate the
safety and performance of the investigational device at 30 days, 6 and 12 months, and 2,
3, 4, 5 years post implantation.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Clinique Pasteur - Toulouse - France | Didier Tchetche, MD | Contact (sur clinicalTrials) | |||
| Hôpital Privé Jacques Cartier - 91300 - Massy - France | Thomas Hovasse, Dr | Contact (sur clinicalTrials) | |||
| Institut Coeur Poumon, CHRU - Lille - France | Arnaud Sudre, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
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1. Subject of age > 75 years
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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
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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
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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
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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
-
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
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4. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
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5. Previous implantation of heart valve in any position
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6. Severe aortic regurgitation (> 3+)
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7. Severe mitral regurgitation (> 3+)
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8. Severe tricuspid regurgitation (> 3+)
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9. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF)
< 30%)
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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
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12. Cardiogenic shock
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13. Untreated cardiac conduction disease in need of pacemaker implantation
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14. Uncontrolled atrial fibrillation (resting heart rate (HR) > 120bpm)
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15. Active and/or suspicion of endocarditis or ongoing sepsis
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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
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18. Any need for emergency surgery
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19. Recent (< 6 months of signing informed consent) CerebroVascular Accident (CVA)
or Transient Ischemic Attack (TIA)
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20. Symptomatic carotid or vertebral artery disease or successful treatment of
carotid stenosis < 30 days prior to signing informed consent
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21. Any active bleeding that precludes anticoagulation
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22. Liver failure (Child-C)
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23. End-stage renal disease requiring chronic dialysis or creatinine clearance <
20cc/min
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24. Pulmonary hypertension (systolic pressure >80mmHg)
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25. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by a Forced
Expiratory Volume (FEV1) < 750cc
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26. Refusal of blood transfusion
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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
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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
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29. Currently participating in another drug or device trial (excluding
observational registries) for which the primary endpoint has not been assessed
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30. Estimated life expectancy of less than 12 months
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31. For females, pregnancy or intention to become pregnant prior to completion of
all follow-up procedures
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32. Inability to comply with the clinical investigation requirements
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33. Subject under judicial protection, tutorship or curatorship (for France only)