CoreValve Evolut Pro Prospective Registry

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.

Clinical Trial Description

The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak. In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03423459
Study type	Observational [Patient Registry]
Source	Medstar Health Research Institute
Contact
Status	Active, not recruiting
Phase
Start date	January 18, 2018
Completion date	December 31, 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
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Withdrawn	`NCT01648309` - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation	N/A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
Completed	`NCT03250806` - Early Detection of Aortic Stenosis in the Community During Flu Vaccination