Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000023055
Ethics application status
Approved
Date submitted
7/01/2010
Date registered
8/01/2010
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Observational, Prospective Evaluation of the St Jude Medical Epic Valve
Scientific title
This is a Multi-centre, Multi-country, Prospective, non-randomized, observational study to confirm the clinical safety and efficacy of the St. Jude Medical (SJM) Epic porcine valve (EPIC), which is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral heart valves.
Secondary ID [1] 1252 0
Nil
Universal Trial Number (UTN)
Trial acronym
EPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Structural Valve Deterioration (SVD) 256480 0
Central regurgitation 256481 0
calcification of the valve 256489 0
Thrombus or Pannus formation 256490 0
Condition category
Condition code
Cardiovascular 256649 256649 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 256665 256665 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims at confirming the clinical safety and efficacy of the St Jude Medical Epic porcine valve by establishing: the adverse effect rates, clinical staus as indicated by the New York Heart Association (NYHA) functional classification and hemodynamic performance.
Once a patient has met all the inclusion/exclusion criteria and signed consent: the patients malfunctioning Aortic or Mitral valve will be removed and replaced with the SJM Epic Valve.
Participants will undergo safety tests including bloods, Echocardiogram, Hypertension etc during Enrollment, discharge, post operative visits: 6 month and 12 month.

The SJM EPIC valve is manufactured from selected porcine aortic valve cusps that have been cross-linked with glutaraldehyde solution. The Valve is suspended on a holder which is secured to the valve with sutures. Depending on the surgeon and the case a surgical procedure will generally take between 2-6hours.
Intervention code [1] 255766 0
Treatment: Devices
Intervention code [2] 255780 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257545 0
The primary objective is to confirm the clinical safety and efficacy of the SJM Epic valve.

This will be assessed through the collection of: Blood tests and Echocardiograms.
Timepoint [1] 257545 0
12 months post implant of SJM Epic valve
Secondary outcome [1] 262785 0
To monitor clinical adverse effect rates. This will be analysed through the collection of the safety data: histopathology reports, operative notes and physicians reported adverse events. Early rates, linearized rates and Kaplan-Meir life tables for: Hemolysis, non-structural dysfunction, paravalvular leak, structural deterioration/failure, bleeding events, embolism, endocarditis, valve thrombosis, reoperation, explant and death.
Timepoint [1] 262785 0
12 months post SJM Epic valve implant. Data will be collected at 6months, 12 months and when notified (at time of occurance).
Secondary outcome [2] 262786 0
To establish clinical status as indicated by NYHA functional classification
Timepoint [2] 262786 0
12 months post SJM Epic valve implant
Secondary outcome [3] 262787 0
To establish the devices hemodynamic performance through the analysing the Echocardiogram results for the mean gradient, peak gradient, effective orifice area, cardiac output, cardiac index and performance index.
Timepoint [3] 262787 0
12 months post SJM Epic Valve implant.

Eligibility
Key inclusion criteria
- The patient requires replacement of the aortic and/or mitral valve
-The patient 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient already has a prosthetic valve, other than an aortic and/or mitral valve being replaced at this occasion
- Patient requries replacement of tricuspid valve or pulmonary valve
- The Patient is pregnant
- The patient has acticve endocarditis
- Patient is undergoing renal dialysis
- The patient has had an acute preoperative neurological event
- the paitient is an intravenous drug abuser, alcoholic or prison inmate

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2002
Actual
1/11/2002
Date of last participant enrolment
Anticipated
29/04/2005
Actual
29/04/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2376 0
5024
Recruitment postcode(s) [2] 2377 0
3065
Recruitment postcode(s) [3] 2378 0
6009

Funding & Sponsors
Funding source category [1] 256252 0
Commercial sector/Industry
Name [1] 256252 0
St Jude Medical
Country [1] 256252 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
St Jude Medical World headquarters
One Lillehei Plaza
St. Paul, MN 55117
Country
United States of America
Secondary sponsor category [1] 251582 0
None
Name [1] 251582 0
Address [1] 251582 0
Country [1] 251582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258342 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 258342 0
Flinders Medical Centre
Flinders Private Hospital
Bedford Park, SA 5024
Ethics committee country [1] 258342 0
Australia
Date submitted for ethics approval [1] 258342 0
29/08/2001
Approval date [1] 258342 0
14/10/2002
Ethics approval number [1] 258342 0
176/034
Ethics committee name [2] 258343 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 258343 0
Second Floor, East Block
The Alfred Hospital
Commercial Rd
Melbourne Vic 3004
Ethics committee country [2] 258343 0
Australia
Date submitted for ethics approval [2] 258343 0
11/10/2002
Approval date [2] 258343 0
30/10/2002
Ethics approval number [2] 258343 0
1/02/0166
Ethics committee name [3] 258344 0
Sir Charles Gairdner Hosptial Human Research Ethics Committee
Ethics committee address [3] 258344 0
Sir Charles Gairdner Hosptial
Hospital Avenue
Nedlands WA 6009
Ethics committee country [3] 258344 0
Australia
Date submitted for ethics approval [3] 258344 0
Approval date [3] 258344 0
20/11/2002
Ethics approval number [3] 258344 0
2002-119
Ethics committee name [4] 258345 0
St Vincents Human Research Ethics Committee
Ethics committee address [4] 258345 0
St Vincents Hospital Melbourne
Research Governance
Unit PO Box 2900
FITZROY VIC 3065
Ethics committee country [4] 258345 0
Australia
Date submitted for ethics approval [4] 258345 0
Approval date [4] 258345 0
01/10/2002
Ethics approval number [4] 258345 0

Summary
Brief summary
The primary purpose of the study is to provide investigators with the information necessary to carry out a clinical evaluation of the SJM Epic Valve. In doing so the study will collect information to establish the adverse effect rates, clinical status as indicated by NYHA functional classification and hemodynamic performance.
Trial website
Trial related presentations / publications
none known
Public notes

Contacts
Principal investigator
Name 30667 0
Dr Michael Yii
Address 30667 0
St Vincents Hospital
41 Victoria Pde
Fitzroy VIC 3065
Country 30667 0
Australia
Phone 30667 0
+61 3 9411 7111
Fax 30667 0
Email 30667 0
[email protected]
Contact person for public queries
Name 13914 0
Mr Gary Jarvis
Address 13914 0
St Jude Medical
One Lillehei Plaza
St Paul, Minnesota 55117
Country 13914 0
United States of America
Phone 13914 0
+1 651 490 4320
Fax 13914 0
+1 651 490 4409
Email 13914 0
[email protected]
Contact person for scientific queries
Name 4842 0
Mr Gary Jarvis
Address 4842 0
St Jude Medical
One Lillehei Plaza
St. Paul, Minnesota 55117
Country 4842 0
United States of America
Phone 4842 0
+1 651 490 4320
Fax 4842 0
+1 651 490 4409
Email 4842 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.