Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

The primary safety and efficacy endpoint is combined safety and efficacy at 30 days, defined as a composite of the following VARC-2 defined components: * All-cause mortality * All stroke (disabling or non-disabling) and transient ischemic attack (TIA) * Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy)

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
Emblok

1 total trials

What the registry record for NCT05295628 still lists

NCT05295628 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, below the 1,025-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (48% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Aortic Valve Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05295628's enrollment target sits among peer trials

532 10th of 30 higher than 21 of 30 other Aortic Valve Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05793151 · 532 participants · NA

    Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

  • NCT06378866 · 532 participants · Phase 2

    Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

  • NCT07219173 · 531 participants · Phase 2

    A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

  • NCT04910685 · 534 participants · Phase 2

    (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05295628, the US trial registry maintained by the National Library of Medicine. NCT05295628 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.