Clinical Trials Logo

Clinical Trial Summary

The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.


Clinical Trial Description

This is a single-arm observational study which includes both prospective and retrospective data. At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively after the ViV procedure (within 37 days post-ViV procedure) with dysfunctional 19mm-25mm INSPIRIS aortic valves, will participate in this study. All subjects will be followed for up to 1 month after the TAVR ViV procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04902053
Study type Observational
Source Edwards Lifesciences
Contact
Status Suspended
Phase
Start date June 2028
Completion date January 2031

See also
  Status Clinical Trial Phase
Completed NCT00774293 - Homoeopathic Association in Aortic Valve Surgery Phase 4
Completed NCT05107453 - Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery Phase 4
Completed NCT01651780 - Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH Phase 3
Completed NCT01187329 - The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose N/A
Recruiting NCT05295628 - Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR N/A
Terminated NCT03680040 - RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
Recruiting NCT05539937 - Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.
Recruiting NCT01522352 - Comparison Between Three Types of Stented Pericardial Aortic Valves N/A
Completed NCT01554709 - Safety and Performance Study of the CardioGard Cannula Phase 2/Phase 3
Completed NCT01404975 - TAVI Protocol - Paravertebral Block Study N/A
Recruiting NCT03889288 - Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer N/A
Active, not recruiting NCT05404880 - INSPIRIS China PMCF Study
Recruiting NCT04652375 - Outcomes After Albumin vs Lactated Ringer's Solution in CABG and AVR Procedures N/A
Recruiting NCT06106451 - Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study) N/A
Completed NCT00860730 - PERCEVAL Pivotal Trial N/A
Active, not recruiting NCT00396760 - Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery Phase 3
Not yet recruiting NCT03603483 - Aortic Root Enlargement in Aortic Valve Replacement N/A
Terminated NCT01368666 - Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark N/A
Recruiting NCT03002272 - Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Active, not recruiting NCT03258333 - Small Aortic Annulus - a New Solution to the Old Problem N/A