Clinical trials: Bioprosthesis Failure
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Bioprosthesis Failure
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China.
- Trial name
- VIV (NCT07174531)
- Testing
- Transcatheter valve in Valve implantation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Beijing Balance Medical Technology Co., Ltd
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Aortic Valve Disorder
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis
- Trial name
- NCT01171625
- Testing
- Implantation of CEP Magna Ease Model 3300TFX
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 283 people
- Sponsor
- Edwards Lifesciences