Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR (NCT05295628)
A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Dignity Health Chandler Regional Medical Center — Chandler, Arizona
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Dignity Health Chandler Regional Medical Center — Chandler, Arizona
- St Joseph's Providence — Orange, California
- Sutter Medical Center Sacramento — Sacramento, California
- Santa Barbara Cottage Hospital — Santa Barbara, California
- Los Robles Hospital and Medical Center — Thousand Oaks, California
- Hartford Hospital — Hartford, Connecticut
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Advocate Christ Medical Center — Oak Lawn, Illinois
- University of Iowa Hospital and Clinics — Iowa City, Iowa
- Ascension Via Christi Hospitals Wichita, Inc. — Wichita, Kansas
- Cardiovascular Institute of the South — Houma, Louisiana
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Henry Ford Hospital — Detroit, Michigan
- Corewell Health — Grand Rapids, Michigan
- University of Washington School of Medicine Barnes Jewish Hospital — St Louis, Missouri
- Integris Baptist Medical Center — Oklahoma City, Oklahoma
- UPMC Pinnacle Harrisburg — Harrisburg, Pennsylvania
- Lankenau Medical Center — Wynnewood, Pennsylvania
- The University of Texas Health Science Center at Houston — Houston, Texas
- Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research — Plano, Texas
- Methodist Hospital — San Antonio, Texas
- Sentra Norfolk General Hospital — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Valve Stenosis
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- Inspiris Resilia Durability Registry — Sankt Pölten,
- Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) — Chandler, Arizona
- Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients — Phoenix, Arizona
- Platelet Adhesion in the Pathobiology of Aortic Stenosis — Charlottesville, Virginia
Explore by condition: All Aortic Valve Stenosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.