Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
Running, not enrolling · Not applicable
Conditions studied: Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
In brief
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.
Key facts
- Study ID
- NCT05295628
- Run by
- Emblok, Inc.
- People needed
- 532
- Starts
- 2023-10-17
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Dignity Health Chandler Regional Medical Center — Chandler, Arizona, United States
- St Joseph's Providence — Orange, California, United States
- Sutter Medical Center Sacramento — Sacramento, California, United States
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States
- Los Robles Hospital and Medical Center — Thousand Oaks, California, United States
- Hartford Hospital — Hartford, Connecticut, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
- Ascension Via Christi Hospitals Wichita, Inc. — Wichita, Kansas, United States
- Cardiovascular Institute of the South — Houma, Louisiana, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Corewell Health — Grand Rapids, Michigan, United States
- University of Washington School of Medicine Barnes Jewish Hospital — St Louis, Missouri, United States
- Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
- UPMC Pinnacle Harrisburg — Harrisburg, Pennsylvania, United States
- Lankenau Medical Center — Wynnewood, Pennsylvania, United States
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
- Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research — Plano, Texas, United States
- Methodist Hospital — San Antonio, Texas, United States
- Sentra Norfolk General Hospital — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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