European Study Evaluating the EMBLOK Embolic Protection System During TAVR

Status Completed

Clinical Trial Summary

The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

Clinical Trial Description

The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Disease

Clinical Trial Details

NCT number	NCT03130491
Study type	Interventional
Source	Innovative Cardiovascular Solutions
Contact
Status	Completed
Phase	N/A
Start date	March 8, 2017
Completion date	January 28, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04149600` - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting	`NCT06001489` - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy	N/A
Not yet recruiting	`NCT04430972` - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed	`NCT02467062` - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Terminated	`NCT02128841` - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.	Phase 2
Active, not recruiting	`NCT01194362` - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting	`NCT05975567` - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting	`NCT06025149` - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed	`NCT05082337` - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures	N/A
Completed	`NCT05193760` - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting	`NCT05941455` - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting	`NCT03924661` - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed	`NCT04073875` - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting	`NCT03121053` - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement	Phase 4
Completed	`NCT02000544` - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit	N/A
Completed	`NCT02981004` - PAR I - Patient-to-Annulus Relation I
Completed	`NCT02688153` - EDWARDS INTUITY Valve System CADENCE Study	N/A
Recruiting	`NCT06126367` - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease