ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

Status: Recruiting
Location: See all (80) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

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

• IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.

• Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.

• IC2. Subject has a documented aortic annulus size of ≥21 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device.

• IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.

• IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.

• IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.

• IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

• IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Locations
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
Arkansas
Baptist Health Medical Center
Recruiting
Little Rock
Arizona
Banner Good Samaritan
Recruiting
Phoenix
HonorHealth Scottsdale Healthcare
Recruiting
Scottsdale
TMC HealthCare
Recruiting
Tucson
California
Scripps Clinic
Recruiting
La Jolla
Cedars-Sinai Heart Institute
Recruiting
Los Angeles
Kaiser Permanente Los Angeles
Recruiting
Los Angeles
University of California, Davis Medical Center
Recruiting
Sacramento
Kaiser Permanente - San Francisco
Recruiting
San Francisco
Stanford University Medical Center
Recruiting
Stanford
Colorado
South Denver Cardiology Associates PC
Recruiting
Littleton
Washington, D.c.
MedStar Washington Hospital Center
Recruiting
Washington
Florida
Morton Plant Hospital
Recruiting
Clearwater
Orlando Regional Medical Center
Recruiting
Orlando
Georgia
Emory University Hospital (Midtown)
Withdrawn
Atlanta
Piedmont Hospital
Recruiting
Atlanta
Iowa
University of Iowa
Recruiting
Iowa City
Illinois
NorthShore University Health Study Coordinator
Recruiting
Evanston
Advocate Christ Medical Center
Recruiting
Oak Lawn
St. John's Hospital (Prairie)
Recruiting
Springfield
Indiana
St. Vincent's Hospital
Recruiting
Indianapolis
Massachusetts
Brigham and Women's Hospital
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
University of Massachusetts
Recruiting
Worcester
Maryland
Union Memorial Hospital
Recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Henry Ford Hospital
Recruiting
Detroit
Minnesota
Abbott Northwestern Hospital
Recruiting
Minneapolis
CentraCare Heart and Vascular Center
Recruiting
Saint Cloud
St. Joseph's Hospital-St. Paul
Recruiting
Saint Paul
Missouri
Barnes Jewish Hospital
Withdrawn
Saint Louis
North Carolina
University of North Carolina
Recruiting
Chapel Hill
Carolinas Medical Center
Recruiting
Charlotte
Wake Forest University School of Medicine
Recruiting
Winston-salem
New Jersey
Deborah Heart and Lung Center
Recruiting
Browns Mills
Englewood Health
Recruiting
Englewood
Robert Wood Johnson Medical Center
Recruiting
New Brunswick
New York
Albany Medical Center
Recruiting
Albany
Montefiore-Jack D. Weiler Hospital
Recruiting
Bronx
Kaleida Health
Recruiting
Buffalo
Columbia University Medical Center/NYPH
Recruiting
New York
Cornell Presbyterian - New York
Recruiting
New York
Mount Sinai Medical Center
Recruiting
New York
Ohio
Lindner Center for Research and Education at Christ Hospital
Recruiting
Cincinnati
Cleveland Clinic
Recruiting
Cleveland
University Hospitals of Cleveland
Recruiting
Cleveland
Mount Carmel Columbus Cardiology Consultants
Withdrawn
Columbus
OhioHealth Research and Innovation Institute
Recruiting
Columbus
Oklahoma
Integris Baptist Medical Center
Recruiting
Oklahoma City
Oregon
Providence Heart Institute
Recruiting
Portland
Sacred Heart Medical Center - Riverbend
Recruiting
Springfield
Pennsylvania
UPMC - Pinnacle
Recruiting
Harrisburg
UPMC Pittsburgh
Recruiting
Pittsburgh
Lankenau
Recruiting
Wynnewood
WellSpan York Hospital
Recruiting
York
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Lexington Medical Center
Recruiting
West Columbia
Tennessee
St Thomas Ascension
Recruiting
Nashville
Texas
Austin Heart
Recruiting
Austin
Baylor Heart and Vascular Hospital
Recruiting
Dallas
Presbyterian Hospital of Dallas
Recruiting
Dallas
The Methodist Hospital Research Institute
Recruiting
Houston
The University of Texas Health Science Center at Houston
Recruiting
Houston
Baylor Regional Medical Center at Plano
Recruiting
Plano
Methodist Healthcare System of San Antonio dba Methodist Hospital
Recruiting
San Antonio
Virginia
University of Virginia Health System
Recruiting
Charlottesville
Sentara Norfolk General Hospital
Recruiting
Norfolk
Vermont
The University of Vermont Medical Center
Recruiting
Burlington
Washington
Providence Regional Medical Center
Recruiting
Everett
Wisconsin
Bellin Health
Recruiting
Green Bay
Aurora Research Institute
Recruiting
Milwaukee
Medical College of Wisconsin - Froedtert Hospital
Recruiting
Milwaukee
Other Locations
Canada
London Health Sciences
Recruiting
London
Centre Hospitalier de l'Universite de Montreal (CHUM)
Recruiting
Montreal
Institut de Cardiologie de Montreal
Recruiting
Montréal
Royal Columbian Hospital
Recruiting
New Westminster
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Recruiting
Québec
Sunnybrook Health Sciences Centre
Recruiting
Toronto
Providence Health - St. Paul's Hospital
Recruiting
Vancouver
Contact Information
Primary
Lisa Currier
Lisa.Currier@bsci.com
508-683-4927
Time Frame
Start Date: June 10, 2019
Estimated Completion Date: February 2033
Participants
Target number of participants: 1670
Treatments
Experimental: ACURATE Valve - Randomized
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.~*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
Experimental: ACURATE Valve - Single-arm Roll-in
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
Active Comparator: Commercial Valve - Randomized
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System~Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.~*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
Authors
Nikos Kakouros, William O'Neill, George Chrysant, Phillip Horwitz, Paul Teirstein, David Zhao, Marc Sintek, Ravi Ramana, Stanley Chetcuti, Thomas Waggoner, Santiago Garcia, Srinivasa Potluri, Mudassar Ahmed, James Hermiller, Dean Kereiakes, Paul Mahoney, Ernesto Ruiz-Rodriguez, Andrew Rassi, Albert Chan, Steven Yakubov, Divya Verma, Robert Leonardi, James Harvey, Samir Kapadia, Apurva Badheka, Justin Levisay, Tsuyoshi Kaneko, Vijay Iyer, Tamim Nazif, Lowell Satler, Eric Gnall, Paul Koh, Ethan Korngold, Joseph Choo, John Wang, Joseph DeGregorio, Brian Stegman, Mark Russo, Ibrahim Sultan, Noah Jones, Mohamed Azeem Latib, David Rizik, Basel Ramlawi, Michael A Morse, Jeffrey Southard, Ashish Pershad, Michael J. Reardon, Abhijeet Dhoble, Robert Stoler, Jeffrey Goldstein, Rahul Sharma, Daniel Steinberg, Harold Dauerman, Michael Rinaldi, Prakash Balan, Jason Ricci, Richard Kovach, John Moscona, Marc Russo, Mustafa Ahmed, Kintur Sanghvi, Annapoorna Kini, Hemal Gada, Nilesh Goswami, Panayotis Fasseas, John Vavalle, Joshua D Rovin, Lee MacDonald, Ashraf Sabe, George Petrossian, Vivek Rajagopal, Sanjay Samy, Somjot Brar, Sudeshna Banerjee, Michael Salinger, Neil Kleiman, Shaym Radhakrishnan, Vijaykumar Kasi, Gregory Von Mering, Guilherme Attizzani, Chandan Devireddy, Ignacio Inglessis, Shing-Chiu Wong, Jeannot Potvin, Pantelis Diamantouros, Chiu Wong, John Webb, James Park, Josep Rodés-Cabau, Christopher Meduri, Tanvir Bajwa, Paul Sorajja, Reda Ibrahim, Raj R Makkar, Scott Lim, Andrew Morse, Jorge Alvarez, Francis Zidar
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

Similar Clinical Trials