Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Aortic Valve Stenosis
Intervention
Medtronic CoreValve System
Location
University of Alberta Hospital
Edmonton
Canada
Status
Active, not recruiting
Source
Medtronic Bakken Research Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01051518
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aortic Valve Stenosis
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Discrete Subaortic Stenosis
A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Stenosis, Supravalvular
A pathological constriction occurring in the region above the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Stenosis, Subvalvular
A pathological constriction occurring in the region below the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Valve Prolapse
The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.
Clinical Trials
CoreValve® System Australia/New Zealand Clinical Study
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 stenosi...
CoreValve Advance International Post Market Study
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
Medtronic CoreValve REDO Study
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 im...
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic va...
Twenty-Five-Year Experience With the Medtronic-Hall Valve Prosthesis
Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet...
PubMed Articles
A prosthesis-patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM a...
The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valv...
Transcatheter aortic valve implantation (TAVI) has become an emerging alternative for high-risk patients with aortic stenosis unsuitable for surgical intervention. We report the case of a 26-mm Edward...
Percutaneous aortic valve in severe valvular regurgitation caused by infective endocarditis.
Recently, the feasibility and safety of percutaneous aortic valve replacement (PAVR) have been reported in the treatment of degenerative aortic valve stenosis in patients at high-risk for surgical aor...
Successful percutaneous aortic valve implantation via a stenotic left subclavian artery access.
Severe aortic valve stenosis may be tackled with percutaneous aortic valve replacement instead of surgical replacement. At present, two CE marked prosthetic valves are available. The CoreValve ReValvi...
