transShield Embolic Protection System Feasibility Study

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

Clinical Trial Description

This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04585308
Study type	Interventional
Source	TransAortic Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	December 15, 2020
Completion date	March 13, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04310046` - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial	N/A
Completed	`NCT03332745` - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting	`NCT06008080` - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting	`NCT06055751` - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting	`NCT04815785` - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis	N/A
Terminated	`NCT02202434` - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement	N/A
Recruiting	`NCT03029026` - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting	`NCT02903420` - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)	N/A
Completed	`NCT02629328` - CardioCel Tri-leaflet Repair Study	N/A
Completed	`NCT02306226` - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Withdrawn	`NCT01648309` - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation	N/A
Completed	`NCT01676727` - ADVANCE Direct Aortic Study
Completed	`NCT01422044` - Risk Prediction in Aortic Stenosis	N/A
Withdrawn	`NCT00774657` - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography	N/A
Terminated	`NCT00535899` - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)	N/A
Terminated	`NCT05070130` - OpSens PRIME CLASS
Completed	`NCT03314857` - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population	N/A
Completed	`NCT04157920` - Impact of Predilatation Between Self-expanding Valves	N/A
Enrolling by invitation	`NCT06212050` - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting	`NCT05893082` - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR	N/A