Medtronic CoreValve REDO Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01051310
First received: January 15, 2010
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Aortic Valve Stenosis
Device: Medtronic CoreValve System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Composite of Major Adverse Events (MAE), including MACCE (Major Adverse Cardiac or Cerebral Event)and MAE. [ Time Frame: discharge and 30 days post-procedure ] [ Designated as safety issue: Yes ]
  • Technical success and procedural success. [ Time Frame: discharge ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2008
Study Completion Date: January 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoreValve Device: Medtronic CoreValve System
Transcatheter Aortic Valve
Other Names:
  • Medtronic CoreValve Transcatheter aortic valve
  • Medtronic CoreValve Percutaneous aortic valve

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051310

Locations
Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Deutsches Herzzentrum München
München, Germany
Netherlands
Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: E. Grube, Prof. Dr. Helios Heart Center Siegburg, Germany
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
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01051310     History of Changes
Other Study ID Numbers: COR-2007-03
Study First Received: January 15, 2010
Last Updated: January 27, 2012
Health Authority: Germany: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 26, 2014