- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01051310
Medtronic CoreValve REDO Study (REDO)
Feasibility Study of Percutaneous Aortic Valve Implantation With the Medtronic CoreValve System for Percutaneous Aortic Valve Replacement (PAVR) in Patients With a Failing Previously Surgically Implanted Aortic Bioprosthesis and Presenting a High Risk for Repeat Surgical Valve Replacement
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Leipzig, Germany
- Herzzentrum Leipzig GmbH
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München, Germany
- Deutsches Herzzentrum München
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-
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Rotterdam, Netherlands
- Erasmus MC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Left ventricular ejection fraction (LVEF) < 20%,
- Creatinine clearance < 20mL/min (estimation using the Cockcroft calculation),
- Renal failure requiring dialysis,
- Permanent and long lasting (> 6 month duration) atrial fibrillation,
- Cirrhosis of the liver (Child class A or B),
- Respiratory impairment (FEV1 < 1L),
- 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),
- Pulmonary hypertension ³ 60mmHg,
- Recurrent pulmonary embolus,
- Moderate tricuspid (< grade 2+) insufficiency,
- Any severe disease contraindicating surgery,
- Calcified aorta (porcelain aorta),
- Recent myocardial infarction (less than 30 days at baseline),
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CoreValve
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Transcatheter Aortic Valve
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of MAE Free Subjects
Time Frame: 30 days post-procedure
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Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes:
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30 days post-procedure
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Technical Success.
Time Frame: 30 days post procedure
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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.
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30 days post procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: G. Schuler, Prof. Dr., Universitat Leipzig Herzzentrum, Germany
- Principal Investigator: R. Lange, Prof. Dr., Deutsches Herzzentrum Munich, Germany
- Principal Investigator: P. de Jaegere, Dr., Erasmus MC Rotterdam, Netherlands
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COR-2007-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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