NCT00187304

Brief Summary

The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

First QC Date

September 15, 2005

Last Update Submit

February 1, 2019

Conditions

Heart Valve Disease

Interventions

Aortic valve replacementDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
  • Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
  • Patient is of legal age in the host country
  • The patient is in sinus rhythm before implantation

You may not qualify if:

  • Patient already has a prosthetic valve, other than the valve being replaced at this time.
  • Patient requires double valve implantation
  • Patient requires concomitant CABG
  • Patients requires intra aortic balloon pump at intervention
  • Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
  • Patient requires ASA or AVK therapy, i.e. not suitable for randomization
  • Patient is pregnant or nursing.
  • Patient is affected by active endocarditis.
  • Patient is affected by aortic dissection.
  • Patient has history of cerebral ischemia
  • Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
  • Patient is affected by peripheral vascular disease requiring treatment
  • Patient has previous chronic anticoagulation therapy
  • Patient is allergic to ASA and/or AVK

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Jean-Phillippe Verhoye, MD

    CHU Pontchaillou Rennes France

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Last Updated

February 4, 2019

Record last verified: 2019-02