Trial record 6 of 220 for:    aortic valve replacement

Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement (ARVA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bernard IUNG, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01293188
First received: February 9, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition
Aortic Valve Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 434
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biopresthetic aortic valve replacement.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with calcified aortic stenosis operated on for bioprosthetic aortic valve replacement

Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293188

Locations
France
Bichat Hospital
Paris, France, 75018
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Bernard Iung AP-HP
  More Information

Publications:
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. Epub 2008 Sep 26. No abstract available.

Responsible Party: Bernard IUNG, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01293188     History of Changes
Other Study ID Numbers: 10185
Study First Received: February 9, 2011
Last Updated: September 27, 2013
Health Authority: France : National Commission on Informatics and Freedoms

Keywords provided by French Cardiology Society:
Aortic Valve Replacement
Bioprosthetic

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014