Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

NAActive, not recruitingINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

October 17, 2023

Primary Completion Date

May 6, 2025

Study Completion Date

October 1, 2025

Conditions
Aortic Valve StenosisAortic Valve DiseaseAortic Valve InsufficiencyAortic Valve Replacement
Interventions
DEVICE

"EMBLOK™ Embolic Protection System (EMBLOK EPS)"

The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

DEVICE

SENTINEL™ Cerebral Protection System

The SENTINEL CPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

Trial Locations (23)

17101

UPMC Pinnacle Harrisburg, Harrisburg

19091

Lankenau Medical Center, Wynnewood

20010

MedStar Washington Hospital Center, Washington D.C.

23507

Sentra Norfolk General Hospital, Norfolk

48109

University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

49503

Corewell Health, Grand Rapids

52242

University of Iowa Hospital and Clinics, Iowa City

60453

Advocate Christ Medical Center, Oak Lawn

63110

University of Washington School of Medicine Barnes Jewish Hospital, St Louis

67226

Ascension Via Christi Hospitals Wichita, Inc., Wichita

70360

Cardiovascular Institute of the South, Houma

73112

Integris Baptist Medical Center, Oklahoma City

75093

Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research, Plano

77030

The University of Texas Health Science Center at Houston, Houston

78229

Methodist Hospital, San Antonio

85224

Dignity Health Chandler Regional Medical Center, Chandler

91360

Los Robles Hospital and Medical Center, Thousand Oaks

92868

St Joseph's Providence, Orange

93105

Santa Barbara Cottage Hospital, Santa Barbara

95816

Sutter Medical Center Sacramento, Sacramento

06106

Hartford Hospital, Hartford

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Yale Cardiovascular Research Group

OTHER

lead

Emblok, Inc.

INDUSTRY

NCT05295628 - Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR | Biotech Hunter | Biotech Hunter