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ACTIVE NOT RECRUITING NA

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

NCT05295628 · View on ClinicalTrials.gov ↗

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.

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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emblok, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05295628 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Michigan, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05295628?

This trial is sponsored by Emblok, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial