Clinical trialNCT05295628Active, not recruitingInterventional

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

SponsorEmblok, Inc.Enrollment532Aortic Valve DiseaseAortic Valve InsufficiencyAortic Valve ReplacementAortic Valve Stenosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Hemal Gada, MD
Heart and Vascular Institute, UPMC Pinnacle
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Oct 2023
Primary completion: 6 May 2025
Completion: 1 Oct 2025
Last update posted: 6 Aug 2025
Registered enrollment: 532
Registry id: NCT05295628

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.