Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

This study is currently recruiting participants.
Verified May 2013 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01531374
First received: February 3, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.


Condition Intervention Phase
Severe Aortic Stenosis
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medtronic CoreValve® Continued Access Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • All-cause Death or Major Stroke [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4500
Study Start Date: February 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medtronic CoreValve® System TAVI
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. High Risk:

    Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days.

    OR

    Extreme Risk:

    Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.

  2. Subject has senile degenerative aortic valve stenosis with:

    • mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND
    • an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
  3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
  4. The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
  5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical

  1. Evidence of an acute myocardial infarction ≤ 30 days before the index procedure.
  2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure for High Risk subjects only.
  3. Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  4. Untreated clinically significant coronary artery disease requiring revascularization.
  5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  6. Need for emergency surgery for any reason.
  7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
  8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  9. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
  10. Active Gastrointestinal (GI) bleeding within the past 3 months.
  11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:

    • aspirin
    • Heparin (HIT/HITTS) and bivalirudin
    • nitinol (titanium or nickel alloy)
    • ticlopidine and clopidogrel
    • contrast media
  12. Ongoing sepsis, including active endocarditis.
  13. Subject refuses a blood transfusion.
  14. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
  15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
  16. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  17. Currently participating in an investigational drug or another device trial.
  18. Symptomatic carotid or vertebral artery disease.

Anatomical

19.

High Risk:

Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.

OR

Extreme Risk:

Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging.

20.Pre-existing prosthetic heart valve any position. 21.Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).

22.Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.

23.Moderate to severe mitral stenosis. 24.Hypertrophic obstructive cardiomyopathy. 25.Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 26.Severe basal septal hypertrophy with an outflow gradient. 27.Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30° (for right subclavian/axillary access).

28. High Risk Ascending aorta diameter >43mm unless the aortic annulus is 20-23 mm in which case the ascending aorta diameter >40 mm.

OR Extreme Risk

Ascending aorta diameter that exceeds the maximum diameter for any given native aortic annulus (see table below):

Aortic Annulus Diameter Ascending Aorta Diameter 18 mm - 20 mm >34 mm 20 mm - 23 mm >40 mm 23 mm - 27 mm >43 mm 27 mm - 29 mm >43 mm 29.Congenital bicuspid or unicuspid valve verified by echocardiography. 30.Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular

31.Transarterial access not able to accommodate an 18Fr sheath.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531374

Contacts
Contact: Lisa Erickson RS.CSTechSupport@medtronic.com

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Recruiting
Phoenix, Arizona, United States
Contact: Timothy Byrne, MD         
Principal Investigator: Timothy Byrne, MD         
Principal Investigator: Michael Caskey, MD         
United States, California
Kaiser Permanente - Los Angeles Medical Center Recruiting
Los Angeles, California, United States
Contact: Vicken Aharonian, MD         
Principal Investigator: Vicken Aharonian, MD         
Principal Investigator: Thomas Pfeffer, MD         
University of Southern California University Hospital Recruiting
Los Angeles, California, United States
Contact: Ray Matthews, MD         
Principal Investigator: Ray Matthews, MD         
Principal Investigator: Vaughn Starnes, MD         
El Camino Hospital Recruiting
Mountain View, California, United States
Contact: James Joye, MD         
Principal Investigator: James Joye, MD         
Principal Investigator: Vincent Gaudiani, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States
Contact: John Giacomini, MD         
Principal Investigator: John Giacomini, MD         
Principal Investigator: Robert Robbins, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States
Contact: Raymond McKay, MD         
Principal Investigator: Raymond McKay, MD         
Principal Investigator: Robert Hagberg, MD         
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States
Contact: Craig Thompson, MD         
Principal Investigator: Craig Thompson, MD         
Principal Investigator: John Elefteriades, MD         
United States, District of Columbia
Washington Hospital Center / Georgetown Hospital Recruiting
Washington, District of Columbia, United States
Contact: Ron Waksman, MD         
Principal Investigator: Ron Waksman, MD         
Principal Investigator: Ammar Bafi, MD         
United States, Florida
University of Miami Health System / Jackson Memorial Hospital Recruiting
Miami, Florida, United States
Contact: Eduardo de Marchena, MD         
Principal Investigator: Eduardo de Marchena, MD         
Principal Investigator: Tomas Salerno, MD         
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States
Contact: Nirat Beohar, MD         
Principal Investigator: Nirat Beohar, MD         
Principal Investigator: Joseph Lamelas, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States
Contact: Vivek Rajagopal, MD         
Principal Investigator: Vivek Rajagopal, MD         
Principal Investigator: James Kauten, MD         
Saint Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States
Contact: Louis Heller, MD         
Principal Investigator: Louis Heller, MD         
Principal Investigator: Steven Macheers, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States
Contact: Ferdinand Leya, MD         
Principal Investigator: Ferdinand Leya, MD         
Principal Investigator: Mamdouh Bakhos, MD         
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States
Contact: James Hermiller, MD         
Principal Investigator: James Hermiller, MD         
Principal Investigator: David Heimansohn, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States
Contact: Atul Chawla, Md         
Principal Investigator: Atul Chawla, MD         
Principal Investigator: David Hockmuth, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States
Contact: Peter Tadros, MD         
Principal Investigator: Peter Tadros, MD         
Principal Investigator: George Zorn, MD         
United States, Louisiana
Cardiovascular Institute of the South/Terrebonne General Recruiting
Houma, Louisiana, United States
Contact: Peter Fail, MD         
Principal Investigator: Peter Fail, MD         
Principal Investigator: Edgar Feinberg, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States
Contact: Jon Resar, MD         
Principal Investigator: Jon Resar, MD         
Principal Investigator: John Conte, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States
Contact: Jeffrey J Popma, MD         
Principal Investigator: Jeffrey J Popma, MD         
Principal Investigator: Kamal Khabbaz, MD         
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States
Contact: Stanley J Chetcuti, MD         
Principal Investigator: Stanley J Chetcuti, MD         
Principal Investigator: G. Michael Deeb, MD         
St. John Hospital and Medical Center Recruiting
Detroit, Michigan, United States
Contact: Thomas Davis, MD         
Principal Investigator: Thomas Davis, MD         
Principal Investigator: Sanjay Batra, MD         
Detroit Medical Center Cardiovascular Institute Recruiting
Detroit, Michigan, United States
Contact: Theodore Schreiber, MD         
Principal Investigator: Theodore Schreiber, MD         
Principal Investigator: Ali Kafi, MD         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States
Contact: William Merhi, DO         
Principal Investigator: William Merhi, MD         
Principal Investigator: John Heiser, MD         
United States, New Jersey
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States
Contact: Robert Kipperman, MD         
Principal Investigator: Robert Kipperman, MD         
Principal Investigator: John Brown, MD         
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States
Contact: Stanley Katz, MD         
Principal Investigator: Stanley Katz, MD         
Principal Investigator: Alan Hartman, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States
Contact: Howard Cohen, MD         
Principal Investigator: Howard Cohen, MD         
Principal Investigator: Gregory Fontana, MD         
NYU Langone Medical Center Recruiting
New York, New York, United States
Contact: James Slater, MD         
Principal Investigator: James Slater, MD         
Principal Investigator: Aubrey Galloway, MD         
The Mount Sinai Medical Center Recruiting
New York, New York, United States
Contact: David H Adams, MD         
Principal Investigator: David H Adams, MD         
Principal Investigator: Samin Sharma, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States
Contact: George Petrossian, MD         
Principal Investigator: George Petrossian, MD         
Principal Investigator: Newell Robinson, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States
Contact: J. Kevin Harrison, MD         
Principal Investigator: J. Kevin Harrison, MD         
Principal Investigator: G. Chad Hughes, MD         
Wake Forest University - Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States
Contact: Robert Applegate, MD         
Principal Investigator: Robert Applegate, MD         
Principal Investigator: Neal Kon, MD         
United States, Ohio
University Hospitals - Case Medical Center Recruiting
Cleveland, Ohio, United States
Contact: Marco Costa, MD         
Principal Investigator: Alan Markowitz, MD         
Principal Investigator: Marco Costa, MD         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States
Contact: Steven Yakubov, MD         
Principal Investigator: Steven Yakubov, MD         
Principal Investigator: Daniel Watson, MD         
The Ohio State University Medical Center - The Richard M. Ross Heart Hospital Recruiting
Columbus, Ohio, United States
Contact: John Cheatham, MD         
Principal Investigator: John Cheatham, MD         
Principal Investigator: Juan Crestanello, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States
Contact: Kimberly Skelding, MD         
Principal Investigator: Kimberly Skelding, MD         
Principal Investigator: Alfred Casale, MD         
Pinnacle Health Recruiting
Harrisburg, Pennsylvania, United States
Contact: Brijeshwar Maini, MD         
Principal Investigator: Brijeshwar Maini, MD         
Principal Investigator: Mubashir Mumtaz, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Joon Sup Lee, MD         
Principal Investigator: Joon Sup Lee, MD         
Principal Investigator: Thomas G Gleason, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Contact: David Zhao, MD         
Principal Investigator: David Zhao, MD         
Principal Investigator: John Bryne, MD         
United States, Texas
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States
Contact: Robert Stoler, MD         
Principal Investigator: Robert Stoler, MD         
Principal Investigator: Robert Hebeler, MD         
Texas Heart Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States
Contact: Jose Diez, MD         
Principal Investigator: Jose Diez, MD         
Principal Investigator: Joseph Coselli, MD         
The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center Recruiting
Houston, Texas, United States
Contact: Neal Kleiman, MD         
Principal Investigator: Neal S Kleiman, MD         
Principal Investigator: Michael Reardon, MD         
United States, Vermont
Fletcher Allen Healthcare Recruiting
Burlington, Vermont, United States
Contact: Harold Dauerman, MD         
Principal Investigator: Harold Dauerman, MD         
Principal Investigator: Joseph Schmoker, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States
Contact: Bryan Raybuck, MD         
Principal Investigator: Bryan Raybuck, MD         
Principal Investigator: Niv Ad, MD         
United States, Washington
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States
Contact: Mike Ring, MD         
Principal Investigator: Mike Ring, MD         
Principal Investigator: Leland Siwek, MD         
United States, Wisconsin
St. Luke's Medical Center - Aurora Health Care Recruiting
Milwaukee, Wisconsin, United States
Contact: Tanvir Bajwa, MD         
Principal Investigator: Tanvir Bajwa, MD         
Principal Investigator: Daniel O'Hair, MD         
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Jeffrey J Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: David H Adams, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01531374     History of Changes
Other Study ID Numbers: 10037989DOC REV 1C
Study First Received: February 3, 2012
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiovascular:
Valvular Heart Disease
Critical Aortic Stenosis
Severe Aortic Stenosis
Extreme Risk
High Risk
Aortic Valve Replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014