Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00329667

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

MedlinePlus related topics: Heart Diseases Heart Valve Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Observational, Prospective Evaluation of the SJM Epic Valve

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
Estimated Study Completion Date:	May 2008

Intervention Details:

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

No Contacts or Locations Provided

More Information

Responsible Party:	St. Jude Medical, Inc. ( Director, Clinical )
Study ID Numbers:	CSD 0206
Study First Received:	May 23, 2006
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00329667
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

heart valve
mitral
aortic
valvular disease

Study placed in the following topic categories:

Heart Diseases
Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009