Clinical trials: Bioprosthetic Valve Degeneration
Aortic Bioprosthesis Degeneration
Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the…
- Trial name
- DURABLE-AORTIC (NCT06964035)
- Testing
- Aortic valve replacement
- Where
- Netherlands
- Volunteers
- 10,000 people
- Sponsor
- Maastricht University Medical Center
Degeneration of Tricuspid Surgical Bioprosthesis
Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement.
The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and…
- Trial name
- DURABLE-TRIC (NCT06875154)
- Testing
- Valve replacement
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Maastricht University Medical Center
Aortic Valve Stenosis
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs.
- Trial name
- NCT05758662
- Testing
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Where
- 4 sites in Denmark, Netherlands and 1 more
- Volunteers
- 180 people
- Sponsor
- St. Antonius Hospital
Degeneration Mitral Bioprosthesis
Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section)…
- Trial name
- DURABLE-Mitral (NCT07151989)
- Testing
- Mitral valve replacement
- Where
- Netherlands
- Volunteers
- 3,500 people
- Sponsor
- Maastricht University Medical Center
Aortic Stenosis, Hypo-attenuated Leaflet Thickening
The HALT Biomarker Study
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis…
- Conditions
- Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration
- Trial name
- HALT (NCT04552275)
- Testing
- Proteomics Analysis
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Massachusetts General Hospital
Degenerative Aortic Valve Disease
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke…
- Trial name
- REPEAT (NCT07462624)
- Testing
- Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement
- Where
- Germany
- Volunteers
- 890 people
- Sponsor
- Heart Center Leipzig - University Hospital