Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
NCT ID: NCT02162069
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
843 participants
INTERVENTIONAL
2014-06-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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transcatheter aortic valve replacement
Patients receive transcatheter aortic valve replacement.
CE certified transcatheter ( aortic valve replacement)
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.
Interventions
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CE certified transcatheter ( aortic valve replacement)
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.
Eligibility Criteria
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Inclusion Criteria
* transcatheter aortic valve replacement
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Jochen Wohrle
Prof. Dr. Jochen Wöhrle
Principal Investigators
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Jochen Wöhrle, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ulm, Ulm, Germany
Locations
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University of Ulm
Ulm, , Germany
Countries
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References
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Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13.
Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.
Seeger J, Gonska B, Rottbauer W, Wohrle J. New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome. Cardiovasc Interv Ther. 2018 Jul;33(3):247-255. doi: 10.1007/s12928-017-0477-6. Epub 2017 Jun 22.
Seeger J, Gonska B, Rottbauer W, Wohrle J. Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jun;10(6):e004670. doi: 10.1161/CIRCINTERVENTIONS.116.004670.
Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.
Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. doi: 10.1371/journal.pone.0151247. eCollection 2016.
Other Identifiers
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CSI TAVR 1.0
Identifier Type: -
Identifier Source: org_study_id
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