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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01675440
First received: August 22, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days associated with surgical aortic valve replacement.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Medtronic CoreValve® U.S. Expanded Use Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Estimated Enrollment: 550
Study Start Date: August 2012
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Severe (≥3-4+) mitral valve regurgitation Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Severe (≥3-4+) tricuspid valve regurgitation Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
End stage renal disease (ESRD)
requiring renal replacement therapy
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Low gradient, low output aortic stenosis Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
2 or more conditions Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Failed bioprosthetic surgical aortic valve Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with symptomatic severe aortic stenosis requiring aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days, and at least one of the following conditions:

  • Severe (≥3-4+) mitral valve regurgitation
  • Severe (≥3-4+) tricuspid valve regurgitation
  • End stage renal disease (ESRD) requiring renal replacement therapy
  • Low gradient, low output aortic stenosis
  • Failed bioprosthetic surgical aortic valve
  • 2 or more conditions (listed above)
Criteria

Inclusion Criteria:

  • 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.
  • Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:

    a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions:

    1. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
    2. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
    3. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification)

      AND

      ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%), AND iii. 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

      AND/OR

      b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization ii. 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 AND iii. radiographic evidence of severe aortic valve calcification c. Failed bioprosthetic surgical aortic valve

  • Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
  • The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical

  • Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure.
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure
  • Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  • Need for emergency surgery for any reason.
  • Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • Active Gastrointestinal (GI) bleeding within the past 3 months.
  • Hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, warfarin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
  • Ongoing sepsis, including active endocarditis.
  • Subject refuses a blood transfusion.
  • Life expectancy <12 months due to associated non-cardiac co-morbid conditions.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
  • Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  • Currently participating in an investigational drug or another device study.
  • Symptomatic carotid or vertebral artery disease.

Anatomical

  • Native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging.
  • Pre-existing prosthetic heart valve in the any position
  • Moderate to severe mitral stenosis.
  • Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed surgical bioprothesis)
  • Hypertrophic obstructive cardiomyopathy.
  • Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation.
  • Severe basal septal hypertrophy with an outflow gradient.
  • 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).
  • Ascending aorta that exceeds the maximum diameter for any given native aortic annulus size (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
  • Congenital bicuspid or unicuspid valve verified by echocardiography.
  • Sinus of valsalva anatomy that would prevent adequate coronary perfusion.
  • Degenerated surgical bioprothesis presents with a significant concomitant perivalvular leak (between prothesis and native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in SAV subjects)
  • Degenerated surgical bioprothesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects)

Vascular

  • Transarterial access not able to accommodate an 18Fr sheath.
  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: NCT01675440

Contacts
Contact: Erin McDowell 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
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         
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         
El Camino Hospital Not yet 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
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         
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States
Contact: Vivek Rajagopal, MD         
Principal Investigator: Vivek Rajagopal, MD         
Principal Investigator: James Kauten, 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         
Detroit Medical Center Cardiovascular Institute Recruiting
Detroit, Michigan, United States
Contact: Theodore Schreiber, MD         
Principal Investigator: Theodore Schreiber, MD         
Principal Investigator: Ali Kafi, 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         
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: Valavanur Subramanian, 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         
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         
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         
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         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States
Contact: Steven Yakubov, MD         
Principal Investigator: Steven Yakubov, MD         
Principal Investigator: Daniel Watson, 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: William D Anderson, MD         
Principal Investigator: William D Anderson, 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         
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         
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         
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 Not yet 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
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01675440     History of Changes
Other Study ID Numbers: 10050361DOC
Study First Received: August 22, 2012
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014