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Medtronic CoreValve REDO Study (REDO)

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic CoreValve System
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Herzzentrum Leipzig GmbH
  • Deutsches Herzzentrum München
  • Erasmus MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CoreValve

Arm Description

Outcomes

Primary Outcome Measures

Percentage of MAE Free Subjects
Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 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. 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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2010
Last Updated
August 20, 2018
Sponsor
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01051310
Brief Title
Medtronic CoreValve REDO Study
Acronym
REDO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoreValve
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve System
Other Intervention Name(s)
Medtronic CoreValve Transcatheter aortic valve, Medtronic CoreValve Percutaneous aortic valve
Intervention Description
Transcatheter Aortic Valve
Primary Outcome Measure Information:
Title
Percentage of MAE Free Subjects
Description
Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 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. 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
Title
Technical Success.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Grube, Prof. Dr.
Organizational Affiliation
Helios Heart Center Siegburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. Schuler, Prof. Dr.
Organizational Affiliation
Universitat Leipzig Herzzentrum, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R. Lange, Prof. Dr.
Organizational Affiliation
Deutsches Herzzentrum Munich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. de Jaegere, Dr.
Organizational Affiliation
Erasmus MC Rotterdam, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
München
Country
Germany
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.medtronic.com
Description
Related Info

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Medtronic CoreValve REDO Study

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