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NCT05295628 · ClinicalTrials.gov registry record · NA

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

A NA study of Aortic Valve Stenosis and Aortic Valve Disease, sponsored by Emblok.

Active
Registry status
NA
Development phase
532
Enrollment target
20
Study locations

NCT05295628 is a NA study of Aortic Valve Stenosis and Aortic Valve Disease that is active but no longer recruiting, run by Emblok. The registered enrollment target is 532 participants, below the 1,025-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05295628, a NA study of Aortic Valve Stenosis and Aortic Valve Disease, is active but no longer recruiting, sponsored by Emblok.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
532 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Replacement

Interventions

  • DEVICE EMBLOK™ Embolic Protection System ("EMBLOK EPS")
  • DEVICE SENTINEL™ Cerebral Protection System

Study Locations (20)

California

  • St Joseph's Providence - Orange
  • Sutter Medical Center Sacramento - Sacramento
  • Santa Barbara Cottage Hospital - Santa Barbara
  • Los Robles Hospital and Medical Center - Thousand Oaks

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Hospital - Detroit
  • Corewell Health - Grand Rapids

Pennsylvania

  • UPMC Pinnacle Harrisburg - Harrisburg
  • Lankenau Medical Center - Wynnewood

Arizona

  • Dignity Health Chandler Regional Medical Center - Chandler

Connecticut

  • Hartford Hospital - Hartford

District of Columbia

  • MedStar Washington Hospital Center - Washington D.C.

Illinois

  • Advocate Christ Medical Center - Oak Lawn

Iowa

  • University of Iowa Hospital and Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 532 participants
Start Date 2023-10-17
Est. Completion 2025-10-01
Phase NA

Sponsor

Emblok

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05295628

The ClinicalTrials.gov registry entry for NCT05295628 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,025-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (48% lower). The listed sponsor is Emblok, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which EMBLOK™ Embolic Protection System ("EMBLOK EPS") is the first listed.

NCT05295628 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Michigan, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05295628 about?

NCT05295628 is a clinical study titled "Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR". 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 comme...

What is the current status of trial NCT05295628?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 532 participants. The study started on 2023-10-17. Estimated completion is 2025-10-01.

What conditions does trial NCT05295628 study?

This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement.

What interventions are being tested in trial NCT05295628?

The interventions under investigation include: EMBLOK™ Embolic Protection System ("EMBLOK EPS") (DEVICE), SENTINEL™ Cerebral Protection System (DEVICE).

Who is sponsoring clinical trial NCT05295628?

This trial is sponsored by Emblok, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05295628 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.