Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
NCT07120048 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-04-02
Summary
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
Conditions
- Aortic Valve Disease
Interventions
- DEVICE
-
Edwards INSPIRIS RESILIA Aortic Valve
Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve
Sponsors & Collaborators
-
Edwards Lifesciences
lead INDUSTRY
Principal Investigators
-
Torsten Doenst, Prof. Dr. med. · Jena University Hospital, University of Jena
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Germany
Study Locations
More Related Trials
-
Inflammatory Response in Aortic Valve Replacement
NCT02324140 ·Status: COMPLETED
-
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
NCT02527629 ·Status: COMPLETED
-
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
NCT03863132 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
NCT03326778 ·Status: COMPLETED
-
INSPIRIS China PMCF Study
NCT05404880 ·Status: ACTIVE_NOT_RECRUITING
-
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
NCT06953206 ·Status: NOT_YET_RECRUITING
-
Transcatheter Aortic Valve Implantation Without Predilation
NCT01539746 ·Status: COMPLETED ·Phase: NA
-
EDWARDS INTUITY Valve System FOUNDATION Study
NCT02338154 ·Status: COMPLETED
-
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
NCT05536310 ·Status: NOT_YET_RECRUITING
-
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT01531374 ·Status: COMPLETED ·Phase: NA
-
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
NCT03112980 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Coronary Artery Disease Assessment Strategies in TAVI Patients
NCT06559332 ·Status: RECRUITING ·Phase: NA
-
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
NCT01787084 ·Status: COMPLETED
-
Valvular Assessment of New Generation Aortic Replacement Devices
NCT06688448 ·Status: RECRUITING ·Phase: NA
-
PrizValve® Transcatheter Aortic Valve Replacement Study
NCT04836897 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
NCT03788590 ·Status: UNKNOWN ·Phase: NA
-
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
NCT02434263 ·Status: UNKNOWN ·Phase: NA
-
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
NCT05261204 ·Status: ENROLLING_BY_INVITATION
-
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
NCT02559011 ·Status: COMPLETED
-
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
NCT07205341 ·Status: RECRUITING
-
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
NCT01532921 ·Status: COMPLETED
-
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
NCT04982406 ·Status: COMPLETED
-
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT02628899 ·Status: COMPLETED ·Phase: NA
-
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
NCT03667248 ·Status: COMPLETED
-
HAART Annuloplasty Device Valve Repair Registry
NCT04035356 ·Status: TERMINATED