Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)

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 Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Medtronic CoreValve System

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada
    • University of Alberta Hospital
  • Montreal, Canada
    • Institut de Cardiologie de Montreal
  • Ottawa, Canada
    • University of Ottawa Heart Institute
• Germany
  • Leipzig, Germany
    • Herzzentrum Leipzig GmbH
  • Siegburg, Germany
    • HELIOS Heart Center Siegburg
• Netherlands
  • Breda, Netherlands
    • Amphia Hospital
  • Rotterdam, Netherlands
    • Erasmus MC
• United Kingdom
  • Leicester, United Kingdom
    • Glenfield Hospital
  • London, United Kingdom
    • Royal Brompton & Harefield NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure,
• ≥ 75 years, or
• Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or

• One or two (but not more than 2) of the following complicating factors:

  1. Cirrhosis of the liver (Child class A or B),
  2. Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter,
  3. Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
  4. Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement,
  5. Porcelain aorta
  6. Recurrent pulmonary embolus,
  7. Right ventricular insufficiency,
  8. Thoracic burning sequelae contraindicating open chest surgery,
  9. History of mediastinum radiotherapy,
  10. Severe connective tissue disease resulting in a contraindication to surgery,
  11. 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 (< 30 days),
• Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
• Any left ventricular or atrial thrombus diagnosed by echocardiography,
• Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
• Mitral or tricuspid valvular insufficiency ( > 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:

  1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
  2. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or
  3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CoreValve	Device: Medtronic CoreValve System; Transcatheter Aortic Valve; Other Names: Medtronic CoreValve Trancatheter Aortic Valve; Medtronic CoreValve Percutaneous Aortic Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Major Adverse Event (MAE) Free Rate	Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.	30 (+7) days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Technical Device Success	Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction. The four measures of the ''Device Functionality Assessment'' were: Load the valve delivery system using the loading system; Access the aortic valve with the delivery catheter; Deploy the valve accurately across the native aortic valve; Remove the intact delivery system	Was assessed during the procedure and completed once the procedure was conlcluded

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: G. Schuler, Prof. Dr., Herzzentrum Universitat Leipzig, Germany; Principal Investigator: R. Bonan, Dr., Institut de Cardiologie de Montreal, Canada; Principal Investigator: J. Kovac, Dr., Glenfield Hospital Leicester, UK; Principal Investigator: P. Serruys, Prof. Dr., Erasmus MC Rotterdam, Netherlands; Principal Investigator: M. Labinaz, Dr., University of Ottawa Heart Institute, Canada; Principal Investigator: P den Heijer, Dr., Amphia Hospital Breda, Netherlands; Principal Investigator: M Mullen, Dr., Royal Brompton & Harefield NHS Trust London, UK; Principal Investigator: W. Tymchak, Dr., University of Alberta Hospital, Canada

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: January 15, 2010
• First Submitted That Met QC Criteria: January 15, 2010
• First Posted (ESTIMATE): January 18, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: COR-2006-02