Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
Public ClinicalTrials.gov record NCT05295628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05295628
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 532 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 17, 2023 (Actual)
- Primary completion
- May 6, 2025 (Actual)
- Completion
- Oct 1, 2025 (Estimated)
- Last update posted
- Aug 6, 2025
2023 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dignity Health Chandler Regional Medical Center | Chandler | Arizona | 85224 | — |
| St Joseph's Providence | Orange | California | 92868 | — |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | — |
| Los Robles Hospital and Medical Center | Thousand Oaks | California | 91360 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| Ascension Via Christi Hospitals Wichita, Inc. | Wichita | Kansas | 67226 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Corewell Health | Grand Rapids | Michigan | 49503 | — |
| University of Washington School of Medicine Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17101 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19091 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research | Plano | Texas | 75093 | — |
| Methodist Hospital | San Antonio | Texas | 78229 | — |
| Sentra Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05295628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05295628 live on ClinicalTrials.gov.