Severe Aortic StenosisNCT04029844
Colibri Transcatheter Aortic Heart Valve System Study
A study testing Colibri TAVI System in people with Severe Aortic Stenosis, run by Colibri Heart Valve LLC at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Colibri TAVI System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Sep 2021to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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+)
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- 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)
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
France3 sites, 3 recruiting
- Recruiting
Institut Coeur Poumon, CHRU
Lille
Arnaud Sudre, MD, 33320445302
- Recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
Thomas Hovasse, Dr, 33160134602
- Recruiting
Clinique Pasteur
Toulouse
Didier Tchetche, MD, 33562211699
United Kingdom2 sites, 2 recruiting
- Recruiting
Brighton & Sussex University Hospital, Roayl Sussex County Hospital
Brighton, East Sussex, BN2 5BE
David Hildick-Smith, MD, 44 1273 696955 ext. 64049, david.hildick-smith@bsuh.nhs.uk
- Recruiting
Barts Heart Centre / St Bartholomew's Hospital
London, EC1A7E
Andreas Baumbach, MD, 442037658740
About this 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
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.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Colibri TAVI System
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colibri TAVI SystemDevice
Implantation of Colibri heart valve
| Study group | Role | What they receive |
|---|---|---|
| Colibri Device | Experimental | Treatment Receives: Device: Colibri TAVI System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality at 30 days post implantation
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start15 Sep 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colibri Heart Valve LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Chevalier, MD, Principal investigator, Hopital Prive Jacques Cartier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029844
- Sponsor's protocol ID
- COL-01
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04029844
- Acronym / sponsor ID
- COL-01
- Conditions
- Severe Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Colibri Heart Valve LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colibri Device | Experimental | Device: Colibri TAVI SystemTreatment |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colibri TAVI SystemImplantation of Colibri heart valve | Device | Colibri Device |
Primary outcome
Rate of all-cause mortality at 30 days post implantation
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Aortic Stenosis
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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
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PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Recruiting
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Aortic Stenosis, Severe, Aortic Valve Stenosis
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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Aortic Stenosis, Severe
Not yet recruiting
Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
Moderate or Severe Aortic Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernard Chevalier, MD principal investigator
Hopital Prive Jacques Cartier
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colibri TAVI System in people with Severe Aortic Stenosis, run by Colibri Heart Valve LLC at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R David Fish, MD (1 (303) 460 8667, colibriTAVI@colibrihv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality at 30 days post implantation (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023; AzTrials last refreshed its copy on 27 Oct 2026.