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

February 1, 2019 updated by: Abbott Medical Devices

An Observational, Prospective Evaluation of the SJM Epic Valve

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.

Study Overview

Status

Completed

Conditions

Valvular Heart Disease

Intervention / Treatment

Device: EPIC

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

Enrollment (Actual)

761

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse effect rates Time Frame: Ongoing	Ongoing
Clinical status as indicated by NYHA functional classification Time Frame: At required follow-up visits	At required follow-up visits
Hemodynamic performance Time Frame: At required follow-up visits	At required follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria