Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Status: Active, not recruiting
Location: See all (86) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;

• Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);

• Subject has severe aortic stenosis presenting with;

• Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND

• Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;

• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;

• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;

• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Locations
United States
Arizona
Banner Good Samaritan Medical Center
Phoenix
California
Cedars-Sinai Medical Center
Hollywood
Scripps Green Hospital
La Jolla
Keck Medical Center of USC
Los Angeles
El Camino Hospital
Mountain View
VA Palo Alto Health Care System
Palo Alto
Southern California Permenente Medical Group
Pasadena
Stanford University Medical Center
Stanford
Connecticut
Hartford Hospital
Hartford
Yale New Haven Hospital
New Haven
Washington, D.c.
Washington Hospital Center
Washington
Florida
Morton Plant Hospital
Clearwater
University of Miami
Coral Gables
Delray Medical Center
Delray Beach
Georgia
Emory University
Atlanta
Piedmont Healthcare, Inc.
Atlanta
Hawaii
The Queen's Medical Center
Honolulu
Iowa
Iowa Heart Center / Mercy Medical Center
West Des Moines
Illinois
Loyola University of Chicago
Maywood
Indiana
St. Vincent Heart Center of Indiana
Indianapolis
Kansas
University of Kansas Hospital
Kansas City
Louisiana
Cardiovascular Institute of the South
Houma
Massachusetts
Beth Israel Deaconess Medical Center, Inc.
Boston
Maryland
The Johns Hopkins University
Baltimore
Michigan
University of Michigan Health Systems
Ann Arbor
Detroit Medical Center
Detroit
Henry Ford
Detroit
St. John Hospital & Medical Center
Detroit
Spectrum Health Hospitals
Grand Rapids
Minnesota
Abbott NW - MN Heart Institute Foundation
Minneapolis
Mayo Clinic - St. Mary's Hospital
Rochester
Missouri
Saint Luke's Hospital/MAHI
Kansas City
North Carolina
Carolinas HealthCare System
Charlotte
Duke University Medical Center
Durham
Wake Forest University Health Sciences
Winston-salem
Nebraska
Alegent Creighton Health Research Center
Omaha
New Jersey
Cooper University Hospital
Camden
Morristown Medical Center
Morristown
New York
North Shore University Hospital
Manhasset
Winthrop University Hospital
Mineola
Columbia University Medical Center
New York
Lenox Hill Hospital
New York
Mount Sinai School of Medicine
New York
New York University School of Medicine
New York
University of Rochester
Rochester
St. Francis Hospital
Roslyn
Ohio
Good Samaritan Hospital
Cincinnati
University Hospitals Case Medical Center
Cleveland
The Ohio State University
Columbus
The OhioHealth Research Institute
Columbus
Oklahoma
Oklahoma Heart Institute
Oklahoma City
Pennsylvania
Geisinger Medical Center
Danville
University of Pennsylvania Health System
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Pinnacle Health Cardiovascular Institute
Wormleysburg
Tennessee
Baptist Memorial Hospital Memphis
Memphis
Vanderbilt University Medical Center
Nashville
Texas
Baylor Heart and Vascular Hospital
Dallas
The Methodist DeBakey Heart & Vascular Center
Houston
The Heart Hospital - Baylor Plano
Plano
Utah
Intermountain Medical Center
Murray
Virginia
Sentara Cardiovascular
Norfolk
Bon Secours St. Mary's Hospital
Richmond
Vermont
University of Vermont
Burlington
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Other Locations
Canada
London Health Sciences Centre, University Hospital
London
McGill University Health Center - Royal Victoria Hospital
Montreal
Montreal Heart Institute
Montreal
Sunnybrook Research Institute
Toronto
Toronto General Hospital (University Health Network)
Toronto
Denmark
Rigshospitalet
Copenhagen
Germany
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen
Universitätsklinikum Bonn
Bonn
Deutsches Herzzentrum Muenchen
Munich
Netherlands
Amphia Hospital Breda
Breda
Medisch Centrum Leeuwarden
Leeuwarden
St. Antonius Hospital, R & D Cardiology
Nieuwegein
Erasmus Medical Center - Rotterdam
Rotterdam
Spain
Servicio de Cardiologia del Hospital Virgen de la Victoria
Malaga
Hospital Universitario Central de Asturias
Oviedo
Sweden
Karolinska Universitetssjukhuset Stockholm
Stockholm
Switzerland
Bern University Hospital
Bern
Universitatsspital Zurich
Zurich
United Kingdom
Leeds General Infirmary
Leeds
Glenfield Hospital, Leicester, UK
Leicester
St. George's Hospital London
London
Time Frame
Start Date: April 2012
Estimated Completion Date: November 2026
Participants
Target number of participants: 1746
Treatments
Experimental: Medtronic CoreValve® System TAVI
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: SAVR
Surgical Aortic Valve Replacement (SAVR)
Authors
John Giacomini, Timothy Byrne, Thomas Davis, Paul Teirstein, Theodore Schreiber, Mark Robbins, Alan Hartman, Stanley J Chetcuti, Kamal Khabbaz, Frank Bowen, Atul Chawla, Peter S Fail, Stanley Katz, James B Hermiller, Daniel Watson, Vicken Aharonian, Paul Mahoney, Robert Hebeler, Mubashir Mumtaz, Basil M Paulus, Brijeshwar Maini, Scott Henry, Joseph Newton, Frederick S. Ling, Raymond McKay, Alan Yeung, Steven Yakubov, Ron Waksman, Robert Hagberg, Joseph Schmoker, Jeffrey Popma, Abeel Mangi, Thomas Pfeffer, Peter Tadros, Samin Sharma, John K Forrest, Christian Spies, Brian Bethea, Jeffrey Lau, Marco Costa, David Hockmuth, Edgar Feinberg, Susheel Kodali, Ammar Bafi, Robert Kipperman, William Merhi, Robert Mark Bodenhamer, Mamdouh Bakhos, Alan Markowitz, Derek Brinster, James Kauten, Neal Kleiman, Tomas A Salerno, Chad Kliger, Peter A. Knight, Thomas Burdon, Newell Robinson, Michael Reardon, J Kevin Harrison, Robert Stoler, Thomas Gleason, Puvi Seshiah, Vinod Thourani, John Conte, William Bachinsky, Alfred Casale, Juan Crestanello, David Scott Lim, David A Heimansohn, Michael Caskey, Gurpreet Sandhu, Kimberly Skelding, Richard Schwartz, Howard Herrmann, David Brown, Janah Aji, Lang Lin, James Slater, Joshua Rovin, Adnan Chhatriwalla, Isaac George, John Brown, George Petrossian, Stephen Ball, Barry George, Vivek Rajagopal, Thomas Walther, Benjamin Sun, Joseph Bavaria, Daniel O'Hair, John Goncalves, Alberto Pochettino, John C Heiser, Wen Chang, Keith Allen, George Trip Zorn, Jeffrey Tyner, Mathew Williams, Rüdiger Lange, Vasilis Babliaros, Sanjay Batra, Robert J. Applegate, Eduardo de Marchena, Marc Robert Katz, Joon Sup Lee, Craig Miller, Mohammad K.J. Ghani, Jon Resar, Harold Dauermann, Ferdinand (Fred) Leya, J Michael Smith, G. Michael Deeb, David Adams, Tanvir Bajwa, Paul Sorajja, Stephan Windecker, Raj Makkar, G Chad Hughes, Neal D. Kon, H. Edward Garrett, William Ryan, A. Pieter Kappetein
Sponsors
Leads: Medtronic Cardiovascular

This content was sourced from clinicaltrials.gov

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