Colibri Transcatheter Aortic Heart Valve System Study
Primary Purpose
Severe Aortic Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colibri TAVI System
Sponsored by
About this trial
This is an interventional treatment trial for Severe Aortic Stenosis
Eligibility 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)
Sites / Locations
- Institut Coeur Poumon, CHRURecruiting
- Hôpital Privé Jacques CartierRecruiting
- Clinique PasteurRecruiting
- Brighton & Sussex University Hospital, Roayl Sussex County HospitalRecruiting
- Barts Heart Centre / St Bartholomew's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colibri Device
Arm Description
Treatment
Outcomes
Primary Outcome Measures
Rate of all-cause mortality at 30 days post implantation
Secondary Outcome Measures
Full Information
NCT ID
NCT04029844
First Posted
July 19, 2019
Last Updated
February 20, 2023
Sponsor
Colibri Heart Valve LLC
1. Study Identification
Unique Protocol Identification Number
NCT04029844
Brief Title
Colibri Transcatheter Aortic Heart Valve System Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colibri Heart Valve LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colibri Device
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Device
Intervention Name(s)
Colibri TAVI System
Intervention Description
Implantation of Colibri heart valve
Primary Outcome Measure Information:
Title
Rate of all-cause mortality at 30 days post implantation
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R David Fish, MD
Phone
1 (303) 460 8667
Email
colibriTAVI@colibrihv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Chevalier, MD
Organizational Affiliation
Hopital Prive Jacques Cartier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Coeur Poumon, CHRU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Sudre, MD
Phone
33320445302
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hovasse, Dr
Phone
33160134602
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Tchetche, MD
Phone
33562211699
Facility Name
Brighton & Sussex University Hospital, Roayl Sussex County Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, MD
Phone
44 1273 696955
Ext
64049
Email
david.hildick-smith@bsuh.nhs.uk
Facility Name
Barts Heart Centre / St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A7E
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Baumbach, MD
Phone
442037658740
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Colibri Transcatheter Aortic Heart Valve System Study
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