Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Status: Active, not recruiting
Location: See all (87) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

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

• Severe aortic stenosis, defined as follows:

• For symptomatic patients:

• Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

• For asymptomatic patients:

• Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR

• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR

• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.

• Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.

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

Locations
United States
Arizona
Abrazo Arizona Heart Hospital
Phoenix
California
Scripps Memorial Hospital La Jolla
La Jolla
University of Southern California University Hospital
Los Angeles
El Camino Hospital
Mountain View
Mercy General Hospital
Sacramento
Los Robles Hospital & Medical Center
Thousand Oaks
Colorado
University of Colorado Hospital
Aurora
Connecticut
Yale New Haven Hospital
New Haven
Florida
Morton Plant Hospital
Clearwater
Delray Medical Center
Delray Beach
HealthPark Medical Center
Fort Myers
University of Miami Hospital
Miami
Tallahassee Research Institute, Inc.
Tallahassee
Georgia
Piedmont Atlanta Hospital
Atlanta
Iowa
Mercy Medical Center
Des Moines
Illinois
Loyola University Medical Center
Maywood
Indiana
Saint Vincent Heart Center of Indiana
Indianapolis
Kansas
The University of Kansas Hospital
Kansas City
Kentucky
Jewish Hospital
Louisville
Louisiana
Terrebonne General Medical Center
Houma
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
Baystate Medical Center
Springfield
Maryland
MedStar Union Memorial Hospital
Baltimore
The Johns Hopkins Hospital
Baltimore
University of Maryland Medical Center
Baltimore
Michigan
University of Michigan Health System
Ann Arbor
Saint John Hospital and Medical Center
Detroit
Spectrum Health Hospitals
Grand Rapids
Minnesota
Abbott Northwestern Hospital
Minneapolis
Missouri
Mercy Hospital
Springfield
North Carolina
Duke University Medical Center
Durham
Wake Forest Baptist Medical Center
Winston-salem
North Dakota
Sanford Medical Center
Fargo
New York
Saint Francis Hospital
East Hills
Saint Joseph's Hospital Health Center
Liverpool
Northwell Health
Manhasset
The Mount Sinai Hospital
New York
Strong Memorial Hospital
Rochester
Ohio
Good Samaritan Hospital
Cincinnati
University Hospitals Case Medical Center
Cleveland
OhioHealth Riverside Methodist Hospital
Columbus
The Ohio State University
Columbus
Oklahoma
Integris Baptist Medical Center
Oklahoma City
Oregon
Oregon Health Science University
Portland
Pennsylvania
Lehigh Valley Hospital
Allentown
Geinsinger Medical Center
Danville
Pinnacle Health
Harrisburg
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas
Baylor Saint Luke's Medical Center
Houston
Houston Methodist Hospital
Houston
Methodist Hospital San Antonio
San Antonio
Utah
University Hospital Salt Lake City Utah
Salt Lake City
Virginia
Saint Mary's Hospital
Richmond
Paramount Heart
Winchester
Vermont
The University of Vermont Medical Center
Burlington
Washington
Swedish Medical Center
Seattle
Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee
Other Locations
Australia
Monash Medical Centre
Clayton
Saint Vincent's Hospital Sydney
Darlinghurst
The Alfred Hospital
Melbourne
Fiona Stanley Hospital (FSH)
Murdoch
Royal North Shore Hospital
St Leonards
Canada
London Health Sciences Centre
London
Glen Royal Victoria (McGill)
Montréal
Montreal Heart
Montréal
IUCPQ
Quebec
Sunnybrook Health Sciences Centre
Toronto
Toronto General Health Hospital
Toronto
France
Centre Hospitalier Régional Universitaire de Lille
Lille
L'Hôpital Privé Jacques Cartier Massy
Massy
Clinique Pasteur
Toulouse
Japan
Sakakibara Heart Institute
Fuchu
Shonan Kamakura General Hospital
Kamakura
Kokura Memorial Hospital
Kitakyushu
Sapporo Higashi Tokushukai Hospital
Sapporo
Sendai Kousei Hospital
Sendai
National Cerebral and Cardiovasclular Center
Suita
Osaka University Hospital
Suita
Teikyo University Hospital
Tokyo
Netherlands
Catharina Ziekenhuis
Eindhoven
St. Antonius Hospital Nieuwegein
Nieuwegein
Erasmus Medisch Centrum
Rotterdam
New Zealand
Waikato Hospital
Hamilton
Time Frame
Start Date: March 2016
Estimated Completion Date: March 2026
Participants
Target number of participants: 2223
Treatments
Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems
Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: Surgical Aortic Valve Replacement (SAVR)
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
Authors
Bart Jenson, Donald Netherland, Guilherme Silva, Timothy Byrne, Thomas Davis, Paul Teirstein, Mark Robbins, David Zhao, Stanley Chetcuti, Kamal Khabbaz, Eric Lehr, Brian Hummel, Thomas Noel, Atul Chawla, Peter Fail, Raymond Singer, Michael J Smith, John Schindler, Ajanta De, David Cox, James Hermiller, Kashish Goel, Merick Kirshner, Sameer Gafoor, Daniel Watson, Robert F. Hebeler, Mubashir Mumtaz, Kendra Grubb, Gregory Fontana, Brijeshwar Maini, Kaushik Mandal, Frederick S. Ling, Ronald Caputo, David Muller, Steven Yakubov, Anthony Rousou, Michael Chang, Frank Ittleman, Joseph Schmoker, Jeffrey Popma, Abeel Mangi, Judah Askew, Robert Merritt, Peter Tadros, Samin Sharma, John Wang, John Forrest, Brian Bethea, Edgar Feinberg II, Wayne Batchelor, Pei Tsau, William Merhi, Sirish Parvathaneni, Nicolas van Mieghem, Alan Markowitz, Steven Burstein, Frederick Welt, Stefano Schena, James Kauten, Neal Kleiman, Jeffrey Sparling, Tomas Salerno, Basel Ramlawi, Douglas Spriggs, Peter Knight, Serguei Melnitchouk, David McGiffin, Newell B. Robinson, Jason Glotzbach, Michael Flaherty, Thomas A Haldis, Michael Reardon, Vaughn A. Starnes, Frank Slachman, J. Kevin Harrison, Robert C. Stoler, Firas Zahr, Thomas G. Gleason, Michael Fiocco, Puvi Seshiah, Daniel Steinberg, John Conte, Harold Dauerman, Alfred Casale, Juan Crestanello, David S. Lim, Joseph Flack, Ray V. Matthews, Kristen Sell-Dottin, David Heimansohn, Rick Esposito, David Fullerton, Roxanne Newman, Kimberly Skelding, Hemal Gada, Bartley Griffith, Julian Hurt, Joseph Coselli, Donald Williams, Joshua Rovin, George A. Petrossian, Clayton Kaiser, Stephen Ball, Mark Bladergroen, Bruce Rutkin, Vishva Dev, David Bull, Ali Gheissari, Daniel O'Hair, John Heiser, James Garrison, Robert S. Farivar, Kevin Lachappelle, George T. Zorn, Jeffrey Tyner, Jan Van der Heyden, Arnaud Farge, Thomas Modine, Arnaud Sudre, Bernard Chevalier, Pierre Berthoumieu, Didier Tchetche, John Carroll, Bob Kiaii, Anuj Gupta, Margreet Bekker, Gerald Yong, Fabian Nietlispach, Sanjay Batra, Ravinay Bhindi, Abdullah Kaya, Ashequl Islam, Junjiro Kobayashi, Robert Larbalestier, Eduardo de Marchena, Marc Katz, Ken Kozuma, Ignacio Inglessis, Howard Song, Nicolo Piazza, Siamak Mohammadi, Seiji Yamazaki, Francesco Maisano, Robert Gooley, Ayman Iskander, Rodrigo Bagur, Murali Mupalla, Craig Elkins, Sam Rakhakrishnan, G. Charles Hughes, Sirish Parvanthaneni, Jon Resar, W.A.L. (Pim) Tonino, Michael Filocco, John Slachman, Ferdinand Leya, Julian Smith, Jospe Rodes-Cadau, Prof. José Paulo Henriques, G. Michael Deeb, Ka Yan Lam, David Adams, Norio Tada, Christopher Meduri, Tanvir Bajwa, Yoshiki Sawa, Paul Sorajja, Robin Heijmen, Raymond Cartier, Shigeru Saito, Kenji Ando, Tetsuya Tobaru, Stephen Fremes, Eric Horlick, Reda Ibrahim, Scott Lilly, Paul Jansz, Adam El-Gamel, Neal Kon, Chris Feindel, Peter Brady, Sanjeevan Pasupati, Tony Walton, J. Michael Tuchek, Jorge Alvarez
Sponsors
Leads: Medtronic Cardiovascular

This content was sourced from clinicaltrials.gov

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