NCT00329667

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3.2 years

First QC Date

May 23, 2006

Last Update Submit

February 1, 2019

Conditions

Valvular Heart Disease

Keywords

heart valvemitralaorticvalvular disease

Outcome Measures

Primary Outcomes (3)

  • Adverse effect rates

    Ongoing

  • Clinical status as indicated by NYHA functional classification

    At required follow-up visits

  • Hemodynamic performance

    At required follow-up visits

Interventions

EPICDEVICE

Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

January 1, 2003

Primary Completion

March 1, 2006

Study Completion

September 1, 2008

Last Updated

February 4, 2019

Record last verified: 2019-02