Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 30, 2018

Primary Completion Date

November 13, 2019

Study Completion Date

December 31, 2030

Conditions
Bicuspid Aortic Valve
Interventions
DEVICE

Medtronic TAVR Systems

Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

Trial Locations (25)

10029

The Mount Sinai Hospital, New York

11030

North Shore University Hospital, Manhasset

11576

Saint Francis Hospital, Roslyn

17101

UPMC Pinnacle Harrisburg Campus, Harrisburg

19085

Paramount Heart, Villanova

30309

Piedmont Atlanta Hospital, Atlanta

32308

Tallahassee Memorial Hospital, Tallahassee

33756

Morton Plant Hospital, Clearwater

33908

HealthPark Medical Center, Fort Myers

43214

OhioHealth Riverside Methodist Hospital, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

48109

University of Michigan Health System, Ann Arbor

49503

Spectrum Health Hospital, Grand Rapids

50314

Mercy Medical Center - Des Moines, Des Moines

53215

Aurora St. Luke's Medical Center, Milwaukee

55407

Abbott Northwestern Hospital, Minneapolis

75226

Baylor Jack and Jane Hamilton Heart & Vascular Hospital, Dallas

77030

Houston Methodist Hospital, Houston

85016

Abrazo Arizona Heart Hospital, Phoenix

91360

Los Robles Hospital & Medical Center, Thousand Oaks

92037

Scripps Memorial Hospital La Jolla, La Jolla

97239

Oregon Health & Science University Hospital, Portland

06510

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY