NCT05295628

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Active, enrolled NA Last updated 6 August 2025

What this trial tests

NA trial testing EMBLOK™ Embolic Protection System ("EMBLOK EPS") in Aortic Valve Stenosis in 532 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2023

Primary endpoint
6 May 2025

1 October 2025

Quick facts

Lead sponsor	Emblok, Inc.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	532
Start date	17 October 2023
Primary completion	6 May 2025
Estimated completion	1 October 2025
Sites	23 locations across United States

Drugs / interventions tested

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

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
• Aortic Valve Disease — all drugs for Aortic Valve Disease →
• Aortic Valve Insufficiency — all drugs for Aortic Valve Insufficiency →
• Aortic Valve Replacement — all drugs for Aortic Valve Replacement →

Sponsor

Emblok, Inc.

Who can join

Adults 18 to 90, any sex, with Aortic Valve Stenosis or Aortic Valve Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fighting Cardiac Thromboembolism during Transcatheter Procedures: An Update on the Use of Cerebral Protection Devices in Cath Labs and EP Labs.
   Preda A, Montalto C, Galasso M, Munafò A, et al · · 2023 · cited 8× · PMID 37763223 · DOI 10.3390/life13091819
2. Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?
   Sayah N, Skalidis I, Mesnier J, Neylon A, et al · · 2024 · cited 4× · PMID 39336957 · DOI 10.3390/jcm13185471
3. Embolic Protection Devices in Transcatheter Aortic Valve Implantation: A Narrative Review of Current Evidence.
   Latsios G, Ktenopoulos N, Apostolos A, Koliastasis L, et al · · 2025 · cited 1× · PMID 40565846 · DOI 10.3390/jcm14124098
4. The efficacy of different types of cerebral embolic protection device during transcatheter aortic valve implantation: a meta-analysis.
   Wang C, Han J, Lu L, Qiu J, et al · · 2024 · cited 1× · PMID 38464846 · DOI 10.3389/fcvm.2024.1205943
5. Neuroprotection Devices in Cardiac Catheterization Laboratories: Does It Sufficiently Protect Our Patients?
   Tan C, Higgins MD, Thanabalasingam V, Sella Kapu C, et al · · 2025 · PMID 40005422 · DOI 10.3390/medicina61020305
6. Insights into calcific aortic valve stenosis: a comprehensive overview of the disease and advancing treatment strategies
   Jain H, Goyal A, Khan A, Khan N, et al · · 2024