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This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral Protection Filter | Other | Patient is treated with Cerebral protection Filter. |
|
| No Cerebral Protection Filter | Other | Patient is not treated with Cerebral protection Filter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI (Medtronic CoreValve) | Device |
| ||
| Claret-Filter |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Size of Cerebral Embolism | Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI). | 2 days after Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leipzig Herzzentrum | Leipzig | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27532914 | Derived | Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lucke C, Woitek F, Holzhey DM, Mohr FW, Gutberlet M, Zivadinov R, Schuler G, Linke A. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA. 2016 Aug 9;316(6):592-601. doi: 10.1001/jama.2016.10302. |
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| 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 |
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| Device |
|
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |