Comparison Between Three Types of Stented Pericardial Aortic Valves

Status Recruiting

Clinical Trial Summary

This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Clinical Trial Description

According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.

Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.

Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Aortic Valve Replacement

Clinical Trial Details

NCT number	NCT01522352
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact	Patrick LACARIN
Phone	04 73 75 11 95
Email	placarin@chu-clermontferrand.fr
Status	Recruiting
Phase	N/A
Start date	March 2012
Completion date	December 2013

View Details

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
Enrolling by invitation	`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.
Completed	`NCT01554709` - Safety and Performance Study of the CardioGard Cannula	Phase 2/Phase 3
Suspended	`NCT04902053` - INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
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