4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Colibri Transcatheter Aortic Heart Valve System Study

Colibri Transcatheter Aortic Heart Valve System Study

Study Description
Brief Summary:

The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, single arm and controlled CE marking clinical investigation compared to recent historical results. This study will be conducted in about 10 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.

60 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.


Condition or disease Intervention/treatment Phase
Severe Aortic Stenosis Device: Colibri TAVI System Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Colibri Device
Treatment
Device: Colibri TAVI System
Implantation of Colibri heart valve

Outcome Measures
Primary Outcome Measures :
  1. Rate of all-cause mortality at 30 days post implantation [ Time Frame: 30 Days ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Subject of age > 18 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 I
  • 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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Julie Ross 1 (303) 460 8667 colibriTAVI@colibri.com

Sponsors and Collaborators
Colibri Heart Valve LLC
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
Rate of all-cause mortality at 30 days post implantation [ Time Frame: 30 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colibri Transcatheter Aortic Heart Valve System Study
Official Title  ICMJE 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
Brief Summary

The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, single arm and controlled CE marking clinical investigation compared to recent historical results. This study will be conducted in about 10 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.

60 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Aortic Stenosis
Intervention  ICMJE Device: Colibri TAVI System
Implantation of Colibri heart valve
Study Arms  ICMJE Experimental: Colibri Device
Treatment
Intervention: Device: Colibri TAVI System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Subject of age > 18 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 I
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Ross 1 (303) 460 8667 colibriTAVI@colibri.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029844
Other Study ID Numbers  ICMJE COL-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Colibri Heart Valve LLC
Study Sponsor  ICMJE Colibri Heart Valve LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Colibri Heart Valve LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP