Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05295628
Study type Interventional
Source Innovative Cardiovascular Solutions
Contact Jeremy Moyer
Phone 610-509-6727
Email jeremy@emblok.com
Status Recruiting
Phase N/A
Start date October 17, 2023
Completion date February 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT05601453 - The ReTAVI Prospective Observational Registry
Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease