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slow enrollment, study device unavailable ( CoreValve)
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Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent predictor of mortality after TAVR. Little is known about potential differences in severity of PAR among different types of aortic valve prosthesis. The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValveĀ® system with main focus on PAR and additional focus on other clinical and imaging endpoints. Primary objective of this study is to investigate the difference in the severity of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValveĀ® bioprosthesis. Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVR and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVR between two available aortic valve prostheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edwards SAPIEN bioprosthesis | Active Comparator | Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis |
|
| Medtronic CoreValveĀ® system | Active Comparator | Transcatheter aortic valve replacement with the Medtronic CoreValve system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement | Procedure | Transcatheter aortic valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE | PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE | Within 5 days after TAVR |
| Measure | Description | Time Frame |
|---|---|---|
| PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging | PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging | Within 5 days after TAVR |
| PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE |
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Inclusion criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Stella, MD, PhD | UMC Utrecht | Principal Investigator |
| Pierfrancesco Agostoni, MD, PhD | UMC Utrecht | Study Chair |
| Nynke Kooistra, MD | UMC Utrecht | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32246266 | Derived | Kooistra NHM, Abawi M, Voskuil M, Urgel K, Samim M, Nijhoff F, Nathoe HM, Doevendans PAFM, Chamuleau SAJ, Leenders GEH, Leiner T, Abrahams AC, van der Worp HB, Agostoni P, Stella PR. Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging. Neth Heart J. 2020 May;28(5):253-265. doi: 10.1007/s12471-020-01414-0. |
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| Medtronic CoreValve system | Device | Transcatheter aortic valve replacement with the Medtronic CoreValve system |
|
| Edwards SAPIEN bioprosthesis | Device | Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis |
|
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE |
| At 6 months +/- 2 weeks after TAVR |
| Clinical endpoints according to the VARC-2 | Clinical endpoints according to the VARC-2 | 30 days, 6months, 1 year |
| Quality of life, presented as scores of the short form 36 item health status survey (SF-36) | Quality of life, presented as scores of the short form 36 item health status survey (SF-36) | 1 year |
| Quality of life, according to the Euroqol questionnaire (EQ-5D) | Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D) | 1 year |
| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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