Aortic Valve StenosisNCT01051518
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
A study testing Medtronic CoreValve System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 countries.
Trial summary
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic CoreValve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 9 sitesin 4 countries
- Study dates
- May 2006to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure,
- ≥ 75 years, or
- Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or
- One or two (but not more than 2) of the following complicating factors:
- Cirrhosis of the liver (Child class A or B),
- Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter,
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- Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
- Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement,
- Porcelain aorta
- Recurrent pulmonary embolus,
- Right ventricular insufficiency,
- Thoracic burning sequelae contraindicating open chest surgery,
- History of mediastinum radiotherapy,
- Severe connective tissue disease resulting in a contraindication to surgery,
- Cachexia (BMI ≤ 18 kg/m²),
- Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,
- Ascending aorta diameter £ 45 mm at the sino-tubular junction, and
- Signed Informed Consent.
Who cannot join
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
- Any sepsis, including active endocarditis,
- Recent myocardial infarction (< 30 days),
- Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
- Any left ventricular or atrial thrombus diagnosed by echocardiography,
- Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
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- Mitral or tricuspid valvular insufficiency ( > grade II),
- Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),
- Any condition considered as contraindication for extracorporeal assistance,
- Evolutive or recent CVA (cerebro vascular accident),
- Poly arterial patients with either:
- Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
- Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or
- Abdominal or thoracic aortic aneurysm,
- Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,
- Evolutive disease with life expectancy less than one year,
- Creatinine clearance < 20 ml/min,
- Pregnancy, and
- Enrolled in another investigational study.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Canada3 sites
University of Alberta Hospital
Edmonton
Institut de Cardiologie de Montreal
Montreal
University of Ottawa Heart Institute
Ottawa
Germany2 sites
Herzzentrum Leipzig GmbH
Leipzig
HELIOS Heart Center Siegburg
Siegburg
United Kingdom2 sites
Glenfield Hospital
Leicester
Royal Brompton & Harefield NHS Trust
London
About this study
Official title: Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Medtronic CoreValve 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.
Medtronic CoreValve SystemDevice
Also called Medtronic CoreValve Trancatheter Aortic Valve, Medtronic CoreValve Percutaneous Aortic Valve
Transcatheter Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| CoreValve | Experimental | Not described Receives: Device: Medtronic CoreValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Adverse Event (MAE) Free Rate
Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.
Measured: 30 (+7) days post procedure
Secondary outcomes (1)
Composite Technical Device Success
Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction.
The four measures of the ''Device Functionality Assessment'' were:
- Load the valve delivery system using the loading system
- Access the aortic valve with the delivery catheter
- Deploy the valve accurately across the native aortic valve
- Remove the intact delivery system
Measured: Was assessed during the procedure and completed once the procedure was conlcluded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMay 2006
- Primary completionFeb 2009
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Grube, Prof. Dr., Principal investigator, Helios Heart Center Siegburg, GermanyG. Schuler, Prof. Dr., Principal investigator, Herzzentrum Universitat Leipzig, GermanyR. Bonan, Dr., Principal investigator, Institut de Cardiologie de Montreal, CanadaJ. Kovac, Dr., Principal investigator, Glenfield Hospital Leicester, UKP. Serruys, Prof. Dr., Principal investigator, Erasmus MC Rotterdam, NetherlandsM. Labinaz, Dr., Principal investigator, University of Ottawa Heart Institute, CanadaP den Heijer, Dr., Principal investigator, Amphia Hospital Breda, NetherlandsM Mullen, Dr., Principal investigator, Royal Brompton & Harefield NHS Trust London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051518
- Sponsor's protocol ID
- COR-2006-02
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2010
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)
- ClinicalTrials.gov ID
- NCT01051518
- Acronym / sponsor ID
- COR-2006-02
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreValve | Experimental | Device: Medtronic CoreValve System |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure,
- ≥ 75 years, or
- Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or
- One or two (but not more than 2) of the following complicating factors:
- Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,
Key exclusion criteria (19 listed)
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
- Any sepsis, including active endocarditis,
- Recent myocardial infarction (< 30 days),
- Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
- Any left ventricular or atrial thrombus diagnosed by echocardiography,
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 |
|---|---|---|
| Medtronic CoreValve SystemAlso: Medtronic CoreValve Trancatheter Aortic Valve, Medtronic CoreValve Percutaneous Aortic ValveTranscatheter Aortic Valve | Device | CoreValve |
Primary outcome
Composite Major Adverse Event (MAE) Free Rate
Time frame: 30 (+7) days post procedure
Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.
1 secondary outcome
Composite Technical Device Success
Time frame: Was assessed during the procedure and completed once the procedure was conlcluded
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
E. Grube, Prof. Dr. principal investigator
Helios Heart Center Siegburg, Germany
G. Schuler, Prof. Dr. principal investigator
Herzzentrum Universitat Leipzig, Germany
R. Bonan, Dr. principal investigator
Institut de Cardiologie de Montreal, Canada
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic CoreValve System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 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 18 inclusion and 19 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: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Germany, Netherlands, 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Major Adverse Event (MAE) Free Rate (time frame: 30 (+7) days post procedure). 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 19 Feb 2019.