Aortic Valve Stenosis
Conditions
Brief 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 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.
Interventions
Transcatheter Aortic Valve
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Cirrhosis of the liver (Child class A or B), 2. Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) \< 1 liter, 3. Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery), 4. Pulmonary hypertension \> 60 mmHg and high risk of cardiac surgery other than valve replacement, 5. Porcelain aorta 6. Recurrent pulmonary embolus, 7. Right ventricular insufficiency, 8. Thoracic burning sequelae contraindicating open chest surgery, 9. History of mediastinum radiotherapy, 10. Severe connective tissue disease resulting in a contraindication to surgery, 11. 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.
Exclusion criteria
* 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), * 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: 1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or 2. Symptomatic carotid or vertebral arteries narrowing (\> 70%) disease, or 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Major Adverse Event (MAE) Free Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Technical Device Success | Was assessed during the procedure and completed once the procedure was conlcluded | 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 |
Countries
Canada, Germany, Netherlands, United Kingdom
Participant flow
Recruitment details
Nine sites from Western Europe and Canada enrolled 126 subjects between May 2006 and November 2008.
Pre-assignment details
Of 126 subjects enrolled, 124 were implanted with the CoreValve aortic valve.
Participants by arm
| Arm | Count |
|---|---|
| High Risk Subjects with a high risk of operative mortality. | 72 |
| Moderate Risk Subjects with a moderate risk of operative mortality. | 54 |
| Total | 126 |
Baseline characteristics
| Characteristic | High Risk | Moderate Risk | Total |
|---|---|---|---|
| Age, Continuous | 81.3 years STANDARD_DEVIATION 7.2 | 83.8 years STANDARD_DEVIATION 4.9 | 82.4 years STANDARD_DEVIATION 6.4 |
| EuroSCORE | 28.9 Percent of predicted operative mortality STANDARD_DEVIATION 14.5 | 16.1 Percent of predicted operative mortality STANDARD_DEVIATION 8.5 | 23.4 Percent of predicted operative mortality STANDARD_DEVIATION 13.8 |
| NYHA NYHA class I | 2 Participants | 5 Participants | 7 Participants |
| NYHA NYHA class II | 12 Participants | 13 Participants | 25 Participants |
| NYHA NYHA class III | 37 Participants | 31 Participants | 68 Participants |
| NYHA NYHA class IV | 21 Participants | 5 Participants | 26 Participants |
| Region of Enrollment Canada | 17 Participants | 14 Participants | 31 Participants |
| Region of Enrollment Germany | 39 Participants | 22 Participants | 61 Participants |
| Region of Enrollment Netherlands | 7 Participants | 9 Participants | 16 Participants |
| Region of Enrollment United Kingdom | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 38 Participants | 34 Participants | 72 Participants |
| Sex: Female, Male Male | 34 Participants | 20 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 47 / 72 | 20 / 54 |
| other Total, other adverse events | 64 / 72 | 47 / 54 |
| serious Total, serious adverse events | 68 / 72 | 46 / 54 |
Outcome results
Primary
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.
Time frame: 30 (+7) days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Risk | Composite Major Adverse Event (MAE) Free Rate | 54.2 Percentage of subjects |
| Moderate Risk | Composite Major Adverse Event (MAE) Free Rate | 48.1 Percentage of subjects |
| Overall Study | Composite Major Adverse Event (MAE) Free Rate | 51.6 Percentage of subjects |
Secondary
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
Time frame: Was assessed during the procedure and completed once the procedure was conlcluded
Population: For two patients in the moderate risk group the composite technical device success could not be calculated because not all measurements required were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Risk | Composite Technical Device Success | 84.7 Percentage of subjects |
| Moderate Risk | Composite Technical Device Success | 80.8 Percentage of subjects |
| Overall Study | Composite Technical Device Success | 83.1 Percentage of subjects |