N/A
N=126
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01051518 ↗Enrolled (actual)
126
Serious AEs
90.5%
Results posted
Feb 2019
Primary outcome: Primary: Composite Major Adverse Event (MAE) Free Rate — 54.2; 48.1; 51.6 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic CoreValve System (Device)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Major Adverse Event (MAE) Free Rate |
54.2; 48.1; 51.6 | — |
| SECONDARY Composite Technical Device Success |
84.7; 80.8; 83.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Native aortic valve disease, defined as valve stenosis with an aortic valve area 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.
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01051518). 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.