Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement (Tissue-Valve)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00465218|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : June 21, 2012
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation
Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
|Recruitment Status :||Completed|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2011|
|Submission Cycle||Results Submitted to ClinicalTrials.gov||Results Returned after Quality Control Review|
October 16, 2019 ||November 7, 2019|
Gohlke-Bärwolf C, Acar J, Oakley C, Butchart E, Burckhart D, Bodnar E, Hall R, Delahaye JP, Horstkotte D, Krémer R, et al. Guidelines for prevention of thromboembolic events in valvular heart disease. Study Group of the Working Group on Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 1995 Oct;16(10):1320-30. Review.
ACC/AHA guidelines for the management of patients with valvular heart disease. A report of the American College of Cardiology/American Heart Association. Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease). J Am Coll Cardiol. 1998 Nov;32(5):1486-588. Review.
Stein PD, Alpert JS, Bussey HI, Dalen JE, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 2001 Jan;119(1 Suppl):220S-227S. Review. Erratum in: Chest 2001 Sep;120(3):1044.
Kirtane AJ, Rahman AM, Martinezclark P, Jeremias A, Seto TB, Manning WJ. Adherence to American College of Cardiology/American Heart Association guidelines for the management of anticoagulation in patients with mechanical valves undergoing elective outpatient procedures. Am J Cardiol. 2006 Mar 15;97(6):891-3. Epub 2006 Feb 2.
Heras M, Chesebro JH, Fuster V, Penny WJ, Grill DE, Bailey KR, Danielson GK, Orszulak TA, Pluth JR, Puga FJ, et al. High risk of thromboemboli early after bioprosthetic cardiac valve replacement. J Am Coll Cardiol. 1995 Apr;25(5):1111-9.
Moinuddeen K, Quin J, Shaw R, Dewar M, Tellides G, Kopf G, Elefteriades J. Anticoagulation is unnecessary after biological aortic valve replacement. Circulation. 1998 Nov 10;98(19 Suppl):II95-8; discussion II98-9.
Gherli T, Colli A, Fragnito C, Nicolini F, Borrello B, Saccani S, D'Amico R, Beghi C. Comparing warfarin with aspirin after biological aortic valve replacement: a prospective study. Circulation. 2004 Aug 3;110(5):496-500.
Rodriguez RA, Rubens F, Rodriguez CD, Nathan HJ. Sources of variability in the detection of cerebral emboli with transcranial Doppler during cardiac surgery. J Neuroimaging. 2006 Apr;16(2):126-32.
Zimmermann N, Roussiekan T, Winter J, Kurt M, Gams E, Wenzel F, Hohlfeld T. Platelet inhibition by aspirin after aortic valve replacement. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1392-3.
Geiser T, Sturzenegger M, Genewein U, Haeberli A, Beer JH. Mechanisms of cerebrovascular events as assessed by procoagulant activity, cerebral microemboli, and platelet microparticles in patients with prosthetic heart valves. Stroke. 1998 Sep;29(9):1770-7.
Sturzenegger M, Beer JH, Rihs F. Monitoring combined antithrombotic treatments in patients with prosthetic heart valves using transcranial Doppler and coagulation markers. Stroke. 1995 Jan;26(1):63-9.