Aortic Valve Stenosis
Conditions
Brief summary
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure. These objectives will be achieved through the following endpoints: * Primary safety endpoint - Composite of Major Adverse Events * Primary performance endpoint - Technical and procedural success at discharge Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.
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
* \> 74 years old, * Symptomatic failing bioprosthetic aortic valve (stenotic, incompetent or mixed) confirmed by Doppler echocardiography, * Logistic EuroSCORE \> 15%, or * Any of the following criteria: 1. Left ventricular ejection fraction (LVEF) \< 20%, 2. Creatinine clearance \< 20mL/min (estimation using the Cockcroft calculation), 3. Renal failure requiring dialysis, 4. Permanent and long lasting (\> 6 month duration) atrial fibrillation, 5. Cirrhosis of the liver (Child class A or B), 6. Respiratory impairment (FEV1 \< 1L), 7. Previous cardiac surgery (i.e., CABG especially if patient had competent mammary arteries on left anterior descending (LAD) artery or occluded saphenous veins with high-risk of coronary embolism during re-operation), 8. Pulmonary hypertension ³ 60mmHg, 9. Recurrent pulmonary embolus, 10. Moderate tricuspid (\< grade 2+) insufficiency, 11. Any severe disease contraindicating surgery, 12. Calcified aorta (porcelain aorta), 13. Recent myocardial infarction (less than 30 days at baseline), 14. Contraindication for cardiopulmonary bypass, * Inner diameter of the failing bioprosthetic aortic valve (homograft or stented or stentless heterograft) of ³ 19mm and \< 26mm as determined by Doppler echocardiography, * Signed informed consent form.
Exclusion criteria
* Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine and clopidogrel, Nitinol, or sensitivity to contrast media which cannot be pre-medicated, * Active infection or endocarditis, * Any intra left ventricular mass, thrombus or vegetation evidenced by Doppler echocardiography, * Mitral or tricuspid valvular insufficiency ³ grade 2+, * Prosthetic mitral or tricuspid valve, * Femoral and/or iliac and/or aortic vascular condition (stenosis, occlusion or tortuosity) that could complicate endovascular access to the aortic valve bioprosthesis, * Symptomatic carotid or vertebral artery narrowing (\> 70%) disease, * Aortic abdominal or thoracic aneurysm, * Bleeding diathesis or coagulopathy, or patient refuses blood transfusion, * Active peptic ulcer or has had upper gastrointestinal bleeding within the past 3 months before baseline, * Moribund status or cachexia with short life-expectancy independent of cardiac condition, * Any acute neurological event or dysfunction occurred in the past 6 weeks before baseline or patient with severe senile dementia, * Therapeutic invasive cardiac procedure, other than balloon aortic valvuloplasty, performed within 30 days prior to study procedure or to be performed during or within 30 days after the study procedure, * Currently, enrolled in this study or another investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of MAE Free Subjects | 30 days post-procedure | Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 1. MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement. 2. MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure. |
| Technical Success. | 30 days post procedure | The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system. |
Countries
Germany, Netherlands
Participant flow
Recruitment details
Three sites in Germany enrolled 18 patients between June 2008 and January 2010.
Pre-assignment details
All 18 subjects signed and informed consent and were admitted to the catheterization laboratory for an attempted implantation. All 18 subjects were subsequently implanted with the CoreValve device.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 18 |
| other Total, other adverse events | 14 / 18 |
| serious Total, serious adverse events | 15 / 18 |
Outcome results
Primary
Percentage of MAE Free Subjects
Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 1. MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement. 2. MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure.
Time frame: 30 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Percentage of MAE Free Subjects | 10 Participants |
Primary
Technical Success.
The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Technical Success. | 17 Participants |