Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

Valvular Heart Disease Clinical Trial

— EPIC  

Official title:

An Observational, Prospective Evaluation of the SJM Epic Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329667
• Other study ID #: CSD 0206
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Est. completion date: September 2008

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: September 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effect rates		Ongoing
Primary	Clinical status as indicated by NYHA functional classification		At required follow-up visits
Primary	Hemodynamic performance		At required follow-up visits