Clinical trials: Bioprosthesis Failure
Bioprosthesis Failure, Allograft
Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either…
- Trial name
- BIOCHOICE (NCT07210541)
- Testing
- aortic valve/root replacement
- Volunteers
- 93 people
- Sponsor
- Chelyabinsk Regional Clinical Hospital
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Surgery, Survival, Prosthesis
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Trial name
- ANDALVALVE (NCT03239509)
- Testing
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Where
- 7 sites in Spain
- Volunteers
- 1,200 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Survival, Prosthesis, Prosthesis Durability
SPAnish Aortic VALVE Multicentric Study
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Survival, Prosthesis, Prosthesis Durability, Valve Heart Disease
- Trial name
- SPAVALVE (NCT03595423)
- Testing
- Surgical AVR with bioprosthetic or mechanical prosthesis
- Where
- Spain
- Volunteers
- 5,000 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Stenosis; Valve, Renal Failure
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences.
- Conditions
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- Trial name
- NCT04581694
- Testing
- TAVI without contrast
- Where
- Brazil
- Volunteers
- 75 people
- Sponsor
- University of Sao Paulo General Hospital
Mitral Insufficiency, Mitral Stenosis
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with…
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure
- Trial name
- NCT05625607
- Testing
- Transcatheter mitral valve-in-valve implantation
- Where
- 7 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
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
Kidney Failure, Renal Dialysis
Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access.
- Trial name
- NCT01021839
- Testing
- Grafts placement
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Massachusetts General Hospital
Bioprosthesis Failure, Mitral Stenosis With Insufficiency
The China Mviv Registry
Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease.
- Conditions
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis, Mitral Regurgitation
- Trial name
- NCT05925335
- Testing
- Transseptal Transcatheter Mitral valve-in-valve Replacement
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
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, 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
Aortic Valve Disease, Artificial Heart Valves
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures.
- Trial name
- TiAra (NCT05998694)
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
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