Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
NCT ID: NCT01293188
Last Updated: 2019-08-14
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
434 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-01-31
Study Completion Date
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The bioprosthetic aortic valve replacement is a frequent intervention because of the predominance of calcified aortic stenosis, which is the most common valvular disease, and aging of the population.
International guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions.
Questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations.
However, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis.
The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.
International guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions.
Questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations.
However, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis.
The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
NCT01269905
Anticoagulation
Mechanical Heart Valve Replacement
COMPLETED
Short- and Medium-term Results of New Generation Aortic
NCT05055089
Echocardiography
Aortic Valve
Cardiac Surgery
+1 more
UNKNOWN
Ischemic And Bleeding Risk Assessment After TAVR
NCT06000943
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
UNKNOWN
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
NCT02080299
Aortic Valve Stenosis
UNKNOWN
PHASE2
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation
NCT02318342
Prosthetic Valve Thrombosis
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will include consecutive patients who agreed to participate in the study, which meet the criteria for inclusion, that is to say consecutive patients operated on by a bioprosthetic aortic valve replacement during the 3 months of inclusion. Patients will be included immediately after completion of aortic valve replacement.
The data will be entered directly by the referent of each center, based on data from the French Society of Cardiology accessible by Internet on a secure site.
The follow-up time will be 6 months
The incidence of thromboembolic complications and bleeding and mortality within 6 months will be analyzed in a standardized manner according to the recommendations on the analysis of morbidity and mortality after valve surgery.
The data will be entered directly by the referent of each center, based on data from the French Society of Cardiology accessible by Internet on a secure site.
The follow-up time will be 6 months
The incidence of thromboembolic complications and bleeding and mortality within 6 months will be analyzed in a standardized manner according to the recommendations on the analysis of morbidity and mortality after valve surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Aortic Valve Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biopresthetic aortic valve replacement.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years old
* Patients operated on for single bioprosthetic aortic valve replacement during the study period:
* with or without reinforcement
* with or without associated CABG
* with or without action on the ascending aorta
* whether a first intervention or reoperation
* Patients who agreed to participate in the study
* Patients operated on for single bioprosthetic aortic valve replacement during the study period:
* with or without reinforcement
* with or without associated CABG
* with or without action on the ascending aorta
* whether a first intervention or reoperation
* Patients who agreed to participate in the study
Exclusion Criteria
* Replacement aortic valve homograft or autograft
* Surgical procedures on another valve (conservative or prosthetic replacement)
* Permanent Atrial Fibrillation
* Processing anticoagulant vitamin K-long course
* Surgical procedures on another valve (conservative or prosthetic replacement)
* Permanent Atrial Fibrillation
* Processing anticoagulant vitamin K-long course
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
French Cardiology Society
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bernard IUNG
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bernard Iung
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bichat Hospital
Paris, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
References
Explore related publications, articles, or registry entries linked to this study.
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
Reference Type
BACKGROUND
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
Reference Type
BACKGROUND
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 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 (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26. No abstract available.
Reference Type
BACKGROUND
Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. doi: 10.1093/eurheartj/ehl428. Epub 2007 Jan 26. No abstract available.
Reference Type
BACKGROUND
Salem DN, O'Gara PT, Madias C, Pauker SG. Valvular and structural heart disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):593S-629S. doi: 10.1378/chest.08-0724.
Reference Type
BACKGROUND
Dunning J, Versteegh M, Fabbri A, Pavie A, Kolh P, Lockowandt U, Nashef SA; EACTS Audit and Guidelines Committee. Guideline on antiplatelet and anticoagulation management in cardiac surgery. Eur J Cardiothorac Surg. 2008 Jul;34(1):73-92. doi: 10.1016/j.ejcts.2008.02.024. Epub 2008 Mar 28.
Reference Type
BACKGROUND
Colli A, Verhoye JP, Heijmen R, Strauch JT, Hyde JA, Pagano D, Antunes M, Koertke H, Ohri SK, Bail DH, Leprince P, Van Straten BH, Gherli T; ACTION Registry Investigators. Antithrombotic therapy after bioprosthetic aortic valve replacement: ACTION Registry survey results. Eur J Cardiothorac Surg. 2008 Apr;33(4):531-6. doi: 10.1016/j.ejcts.2007.12.019. Epub 2008 Jan 18.
Reference Type
BACKGROUND
Vaughan P, Waterworth PD. An audit of anticoagulation practice among UK cardiothoracic consultant surgeons following valve replacement/repair. J Heart Valve Dis. 2005 Sep;14(5):576-82.
Reference Type
BACKGROUND
Aramendi JI, Mestres CA, Martinez-Leon J, Campos V, Munoz G, Navas C. Triflusal versus oral anticoagulation for primary prevention of thromboembolism after bioprosthetic valve replacement (trac): prospective, randomized, co-operative trial. Eur J Cardiothorac Surg. 2005 May;27(5):854-60. doi: 10.1016/j.ejcts.2004.12.064.
Reference Type
BACKGROUND
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. doi: 10.1161/01.cir.0000137122.95108.52.
Reference Type
BACKGROUND
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. doi: 10.1016/0735-1097(94)00563-6.
Reference Type
BACKGROUND
Orszulak TA, Schaff HV, Mullany CJ, Anderson BJ, Ilstrup DM, Puga FJ, Danielson GK. Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis. Ann Thorac Surg. 1995 Feb;59(2):462-8. doi: 10.1016/0003-4975(94)00862-2.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Blair KL, Hatton AC, White WD, Smith LR, Lowe JE, Wolfe WG, Young WG, Oldham HN, Douglas JM Jr, Glower DD. Comparison of anticoagulation regimens after Carpentier-Edwards aortic or mitral valve replacement. Circulation. 1994 Nov;90(5 Pt 2):II214-9.
Reference Type
BACKGROUND
Sundt TM, Zehr KJ, Dearani JA, Daly RC, Mullany CJ, McGregor CG, Puga FJ, Orszulak TA, Schaff HV. Is early anticoagulation with warfarin necessary after bioprosthetic aortic valve replacement? J Thorac Cardiovasc Surg. 2005 May;129(5):1024-31. doi: 10.1016/j.jtcvs.2004.11.028.
Reference Type
BACKGROUND
Brueck M, Kramer W, Vogt P, Steinert N, Roth P, Gorlach G, Schonburg M, Heidt MC. Antiplatelet therapy early after bioprosthetic aortic valve replacement is unnecessary in patients without thromboembolic risk factors. Eur J Cardiothorac Surg. 2007 Jul;32(1):108-12. doi: 10.1016/j.ejcts.2007.03.031. Epub 2007 Apr 20.
Reference Type
BACKGROUND
Iung B. Management of the elderly patient with aortic stenosis. Heart. 2008 Apr;94(4):519-24. doi: 10.1136/hrt.2007.122804. No abstract available.
Reference Type
BACKGROUND
Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10185
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effective Management of Calcific Aortic Stenosis in the Elderly
NCT03343314
COMPLETED
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
NCT03411304
ACTIVE_NOT_RECRUITING
Risk Stratification Post TAVI Using TEG
NCT03649594
UNKNOWN
Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation
NCT03135496
COMPLETED
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
NCT04663334
COMPLETED
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
NCT05708118
UNKNOWN
Portico Valve-in-Valve Retrospective Registry
NCT05002088
COMPLETED
Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU
NCT03259945
COMPLETED
Left Bundle Branch Block (LBBB) After IntuityTM
NCT04897659
COMPLETED
Coronary Artery Disease in Elderly People Referred for TAVI
NCT04930510
UNKNOWN
Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT
NCT02426307
ACTIVE_NOT_RECRUITING
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
NCT03667365
TERMINATED
NA
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
NCT04557345
COMPLETED
Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy
NCT01569334
UNKNOWN
NA
Long-term Prognosis and Valve Durability of TAVR
NCT06379386
RECRUITING
Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
NCT06964035
ENROLLING_BY_INVITATION
Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
NCT03015818
COMPLETED
PHASE4
The ENDOCARDITIS AUMC Data Collection
NCT05139589
RECRUITING
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
NCT03613246
ACTIVE_NOT_RECRUITING
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
NCT05714293
ENROLLING_BY_INVITATION
NA
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
NCT06168370
RECRUITING
NA
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
NCT02812953
UNKNOWN
Neurocognitive Assessment in TAVI
NCT06120946
COMPLETED
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
NCT02162069
COMPLETED
NA