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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00329667
First received: May 23, 2006
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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 Intervention
Valvular Heart Disease
Device: EPIC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Observational, Prospective Evaluation of the SJM Epic Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Adverse effect rates [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • Clinical status as indicated by NYHA functional classification [ Time Frame: At required follow-up visits ] [ Designated as safety issue: No ]
  • Hemodynamic performance [ Time Frame: At required follow-up visits ] [ Designated as safety issue: No ]

Enrollment: 761
Study Start Date: January 2003
Study Completion Date: September 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EPIC
    Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00329667     History of Changes
Other Study ID Numbers: CSD 0206
Study First Received: May 23, 2006
Last Updated: September 9, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014