Clinical trial NCT00883285: Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
Official title: Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Aortic Valve Disease
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic valve disease

Brief summary: The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Detailed description: Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Eligibility criteria: Inclusion Criteria:

* aortic valve replacement

Exclusion Criteria:

* contraindication to undergo MRI

Primary outcomes:
measure: Silent cerebral embolism
timeFrame: 48 hours
Secondary outcomes:
measure: Apparent cerebral embolism
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
state: NRW
Study officials:
References:
citation: Doerner J, Kupczyk PA, Wilsing M, Luetkens JA, Storm K, Fimmers R, Hickethier T, Eichhorn L, Naehle CP, Schild HH, Werner N, Nickenig G, Ghanem A. Cerebral white matter lesion burden is associated with the degree of aortic valve calcification and predicts peri-procedural cerebrovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). Catheter Cardiovasc Interv. 2018 Mar 1;91(4):774-782. doi: 10.1002/ccd.27122. Epub 2017 May 26.
citation: Ghanem A, Kocurek J, Sinning JM, Wagner M, Becker BV, Vogel M, Schroder T, Wolfsgruber S, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Thomas D, Werner N, Grube E, Nickenig G, Muller A. Cognitive trajectory after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2013 Dec;6(6):615-24. doi: 10.1161/CIRCINTERVENTIONS.112.000429. Epub 2013 Oct 15.
citation: Ghanem A, Muller A, Sinning JM, Kocurek J, Becker BV, Vogel M, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Nahle CP, Thomas D, Wagner M, Grube E, Werner N, Nickenig G. Prognostic value of cerebral injury following transfemoral aortic valve implantation. EuroIntervention. 2013 Mar;8(11):1296-306. doi: 10.4244/EIJV8I11A198.
citation: Ghanem A, Muller A, Sinning JM, Kocurek J, Becker BV, Vogel M, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Nahle CP, Thomas D, Wagner M, Grube E, Werner N, Nickenig G. Prognostic value of cerebral injury following transfemoral aortic valve implantation. EuroIntervention. 2012 Nov 22:20120710-05. Online ahead of print.
citation: Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010 Apr 6;55(14):1427-32. doi: 10.1016/j.jacc.2009.12.026. Epub 2010 Feb 24.