Clinical Trials Logo
  1. Home
  2. Aortic Stenosis
  3. NCT05893082

Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Aortic Stenosis Clinical Trial

Official title:
A Prospective, Single-Arm, Multicenter Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement

Clinical Trial Summary

The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement procedure. Participants will complete several neurocognitive assessments and an MRI procedure.

Clinical Trial Description

The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement procedure. The F2 device is inserted via a transfemoral approach and positioned in the aorta to cover and protect the three great cerebral vessels from any debris released during the valve replacement procedure. The F2 device remains in place during the aortic valve replacement procedure. After the valve is placed, the F2 device is removed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05893082
Study type Interventional
Source EnCompass Technologies, Inc.
Contact Kathleen Calderon
Phone 307-250-2726
Email kcalderon@encompassf2.com
Status Recruiting
Phase N/A
Start date September 12, 2023
Completion date January 2024
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
Completed NCT03250806 - Early Detection of Aortic Stenosis in the Community During Flu Vaccination