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Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve (EPIC)

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ClinicalTrials.gov Identifier: NCT00329667
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
St. Jude Medical

Brief Summary:
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Device: EPIC Not Applicable

Detailed Description:

This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:

  • adverse effect rates
  • clinical status as indicated by NYHA functional classification
  • hemodynamic performance

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 761 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observational, Prospective Evaluation of the SJM Epic Valve
Study Start Date : January 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : September 2008

Intervention Details:
    Device: EPIC
    Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves


Primary Outcome Measures :
  1. Adverse effect rates [ Time Frame: Ongoing ]
  2. Clinical status as indicated by NYHA functional classification [ Time Frame: At required follow-up visits ]
  3. Hemodynamic performance [ Time Frame: At required follow-up visits ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
  • The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
  • The patient is of legal age in host country.

Exclusion Criteria:

  • Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
  • The patient requires replacement of the tricuspid or pulmonary valve.
  • The patient is pregnant or nursing.
  • Patient has active endocarditis.
  • Patient is actively participating in the study of an investigational drug or device.
  • Patient has had an acute preoperative neurological event.
  • The patient is undergoing renal dialysis.
  • Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
  • Patient has an inability or unwillingness to return for the required follow-up intervals.
  • The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.

Responsible Party: Sr. Director, Clinical, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00329667     History of Changes
Other Study ID Numbers: CSD 0206
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by St. Jude Medical:
heart valve
mitral
aortic
valvular disease

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases