Observational Study of Prosthetic Tissue Aortic and Mitra... | NCT00329667

Studies
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

NCT00329667

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

761Actual

Phase

Not Applicable

Conditions

Valvular Heart Disease

Interventions

EPIC

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Sep 2008Actual

First Submitted Date

May 23, 2006

First Submission Date that Met QC Criteria

May 23, 2006

First Posted Date

May 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

761Actual

Name	Type	Description	Arm Group Labels	Other Names
EPIC	Device	Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases