N/A
N=634
CoreValve® System Australia/New Zealand Clinical Study
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01015612 ↗Enrolled (actual)
634
Serious AEs
84.2%
Results posted
Oct 2018
Primary outcome: Primary: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate — 0.099 probability of events at 30 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic CoreValve® System (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiovascular
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate |
0.099 | — |
| PRIMARY Percentage of Participants With Overall Device Success |
52.6 | — |
| PRIMARY Cardiac-related Death |
0.035 | — |
| SECONDARY All-Cause Mortality |
0.038 | — |
| SECONDARY Myocardial Infarction |
0.021 | — |
| SECONDARY Stroke |
0.043 | — |
| SECONDARY Re-intervention |
0.019 | — |
Summary
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
Eligibility Criteria
Inclusion Criteria
- Documented severe aortic valve stenosis
- Access vessel diameter >6 mm as defined pre procedure via angiographic measure
- Aortic valve annulus diameter ≥ 20 mm and 60 mmHg and high probability of cardiac surgery for other than valve replacement
- 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 (clinical impression)
- Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit
Exclusion Criteria
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
- Any sepsis, including active endocarditis.
- Recent myocardial infarction ( grade II)
- Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
- Evolutive or recent CVA (cerebrovascular accident), ( 70%) disease
- Abdominal or thoracic aortic aneurysm
- Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
- Evolutive disease with life expectancy less than one year
- Creatinine clearance < 20 ml/min
- Active gastritis or known peptic ulcer disease
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01015612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.