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

Status: Active_not_recruiting
Location: See all (75) 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: f
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 ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]) and, for the Main Randomized Cohort and the Extended Durability Study, 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
Birmingham
Arkansas
Baptist Health Medical Center
Little Rock
Arizona
Banner Good Samaritan
Phoenix
HonorHealth Scottsdale Healthcare
Scottsdale
TMC HealthCare
Tucson
California
Scripps Clinic
La Jolla
Cedars-Sinai Heart Institute
Los Angeles
Kaiser Permanente Los Angeles
Los Angeles
University of California, Davis Medical Center
Sacramento
Kaiser Permanente - San Francisco
San Francisco
Stanford University Medical Center
Stanford
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
Morton Plant Hospital
Clearwater
Orlando Regional Medical Center
Orlando
Georgia
Piedmont Hospital
Atlanta
Iowa
University of Iowa
Iowa City
Illinois
NorthShore University Health Study Coordinator
Evanston
Advocate Christ Medical Center
Oak Lawn
St. John's Hospital (Prairie)
Springfield
Indiana
St. Vincent's Hospital
Indianapolis
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
University of Massachusetts
Worcester
Maryland
Union Memorial Hospital
Baltimore
Michigan
University of Michigan
Ann Arbor
Henry Ford Hospital
Detroit
Minnesota
Abbott Northwestern Hospital
Minneapolis
CentraCare Heart and Vascular Center
Saint Cloud
St. Joseph's Hospital-St. Paul
Saint Paul
North Carolina
University of North Carolina
Chapel Hill
Carolinas Medical Center
Charlotte
Wake Forest University School of Medicine
Winston-salem
New Jersey
Deborah Heart and Lung Center
Browns Mills
Englewood Health
Englewood
Robert Wood Johnson Medical Center
New Brunswick
New York
Albany Medical Center
Albany
Montefiore-Jack D. Weiler Hospital
Bronx
Kaleida Health
Buffalo
Columbia University Medical Center/NYPH
New York
Cornell Presbyterian - New York
New York
Mount Sinai Medical Center
New York
Ohio
Lindner Center for Research and Education at Christ Hospital
Cincinnati
Cleveland Clinic
Cleveland
University Hospitals of Cleveland
Cleveland
OhioHealth Research and Innovation Institute
Columbus
Oklahoma
Integris Baptist Medical Center
Oklahoma City
Oregon
Providence Heart Institute
Portland
Sacred Heart Medical Center - Riverbend
Springfield
Pennsylvania
UPMC - Pinnacle
Harrisburg
UPMC Pittsburgh
Pittsburgh
Lankenau
Wynnewood
WellSpan York Hospital
York
South Carolina
Medical University of South Carolina
Charleston
Lexington Medical Center
West Columbia
Tennessee
St Thomas Ascension
Nashville
Texas
Austin Heart
Austin
Baylor Heart and Vascular Hospital
Dallas
Presbyterian Hospital of Dallas
Dallas
The Methodist Hospital Research Institute
Houston
The University of Texas Health Science Center at Houston
Houston
Baylor Regional Medical Center at Plano
Plano
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio
Virginia
University of Virginia Health System
Charlottesville
Sentara Norfolk General Hospital
Norfolk
Vermont
The University of Vermont Medical Center
Burlington
Washington
Providence Regional Medical Center
Everett
Wisconsin
Bellin Health
Green Bay
Aurora Research Institute
Milwaukee
Medical College of Wisconsin - Froedtert Hospital
Milwaukee
Other Locations
Canada
London Health Sciences
London
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal
Royal Columbian Hospital
New Westminster
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
Sunnybrook Health Sciences Centre
Toronto
Providence Health - St. Paul's Hospital
Vancouver
Time Frame
Start Date: 2019-06-10
Completion Date: 2034-09
Participants
Target number of participants: 1948
Treatments
Experimental: ACURATE Valve - Main 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 - Main 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.
Experimental: ACURATE Valve - Single-arm Prime XL
Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL.~\*50 subjects will be enrolled in the Prime™ XL Nested Registry
Experimental: ACURATE Valve - Extended Durability Randomized
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.
Active_comparator: Commercial Valve - Extended Durability 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. Only low risk patients are enrolled in this group.
Experimental: ACURATE Valve - Continued Access Study
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov