Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

NCT ID: NCT00883285

Last Updated: 2014-02-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Cerebral Stroke Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

conventional aortic valve replacement

No interventions assigned to this group

2

transfemoral aortic valve replacement

No interventions assigned to this group

3

transapical aortic valve replacement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* aortic valve replacement

Exclusion Criteria

* contraindication to undergo MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Claas P. Naehle

Assistant Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28547872 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24129642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23538093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23186915 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20188503 (View on PubMed)

Other Identifiers

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255/08

Identifier Type: -

Identifier Source: org_study_id

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