NCT05295628

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (estimated)
• Sponsor: Emblok, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Embolic stroke remains a major complication for TAVR, resulting in a two-fold increase in 1-year mortality. Embolic protection devices have been developed to filter embolic debris during the procedure, potentially reducing the occurrence of neurologic events associated with TAVR. The EMBLOK EPS may improve on currently available devices by capturing and retrieving debris directed toward all 3 cerebral vessels in the aortic arch as well as the descending aorta. 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. With this comparator device, the left subclavian artery and descending aorta are not protected. 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. Prior to enrollment of the first randomized subject at each site, each site will enroll 2 Roll-In subjects (up to 60 subjects total), who will not be randomized but will receive the EMBLOK EPS during TAVR. In the randomized cohort, up to 422 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site) to one of two treatment arms: 1. Intervention - EMBLOK EPS during TAVR 2. Control - SENTINEL CPS during TAVR In addition, a nested registry will enroll up to 50 subjects who meet clinical eligibility criteria and are anatomically suitable for the EMBLOK EPS, but whose anatomy precludes the use of the SENTINEL CPS. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.

Conditions

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

Interventions

Type	Name	Description
DEVICE	EMBLOK™ Embolic Protection System ("EMBLOK EPS")	The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
DEVICE	SENTINEL™ Cerebral Protection System	The SENTINEL CPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-05-06
• Completion: 2025-10-01
• First posted: 2022-03-25
• Last updated: 2025-08-06

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study