Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000303246
Ethics application status
Approved
Date submitted
10/04/2009
Date registered
19/05/2009
Date last updated
19/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective randomized study to determine the clinical outcomes of tissue and mechanical aortic valve replacement in patients aged 55-70yrs.
Scientific title
Prospective randomized study to determine the clinical outcomes of tissue and mechanical aortic valve replacement in patients aged 55-70yrs.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic valve disease 4583 0
Condition category
Condition code
Cardiovascular 4880 4880 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following a median sternotomy, patients are supported by a cardiopulmonary bypass machine before surgical aortic valve replacement using a Mosaic tissue valve. The type of valve replaced will be predetermined through randomization prior to surgery.
Intervention code [1] 4347 0
Treatment: Surgery
Intervention code [2] 4348 0
Treatment: Devices
Comparator / control treatment
Following a median sternotomy, patients are supported by a cardiopulmonary bypass machine before surgical aortic valve replacement using St Judes mechanical valve. The type of valve replaced will be predetermined through randomization prior to surgery.
Control group
Active

Outcomes
Primary outcome [1] 5730 0
Long term survival: monitored by health care professionals via the telephone, clinic appointments and medical records.
Timepoint [1] 5730 0
Post operatively and six monthly after surgery until end of follow up (up to 10 years).
Primary outcome [2] 5731 0
Freedom from hospitalisation: monitored by health care professionals via the telephone, clinic appointments and medical records.
Timepoint [2] 5731 0
Six monthly after surgery until end of follow up (up to 10 years)
Primary outcome [3] 5732 0
Quality of life measures: monitored by health care professionals using the SF-36 questionnaire.
Timepoint [3] 5732 0
At baseline and six months after surgery
Secondary outcome [1] 241670 0
Predictors of early and late mortality: will be monitored by health care professionals via telephone, clinic appointments and medical records.
Timepoint [1] 241670 0
Post operatively and 6 monthly post surgery until end of follow-up (up to 10 years)
Secondary outcome [2] 241671 0
Freedom from Transient Ischemic Attack (TIA), stroke and thromboembolic episodes: monitored by health care professionals via telephone, clinic appointments and medical records.
Timepoint [2] 241671 0
Post operatively and 6 monthly post surgery until end of follow-up (up to 10 years)
Secondary outcome [3] 241672 0
Freedom from endocarditis: indicated by positive blood cultures, vegetations on the echocardiogram and monitored by health care professionals both in hospital and post discharge via telephone and clinic appointments.
Timepoint [3] 241672 0
Post operatively and 6 monthly post surgery until end of follow-up (up to 10 years)
Secondary outcome [4] 241673 0
Freedom from hemorrhagic complications: monitored by health care professionals both in hospital and post discharge via telephone and clinic appointments.
Timepoint [4] 241673 0
Post operatively and 6 monthly post surgery until end of follow-up (up to 10 years)
Secondary outcome [5] 241674 0
Rate of readmission: monitored by health care professionals via telephone, clinic appointments and medical records.
Timepoint [5] 241674 0
6 monthly post surgery until end follow-up (up to 10 years)
Secondary outcome [6] 241675 0
Freedom from valve failure: measured by health care professionals and echocardiogram performed at 6 months and two yearly intervals until end of follow up (up to 10 years).
Timepoint [6] 241675 0
Postoperatively and 6 monthly post surgery until end of follow-up (up to 10 years)

Eligibility
Key inclusion criteria
Patients requiring Aortic Valve Replacement in the age group 55-70.
Minimum age
55 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking
Contraindication to anticoagulation
Renal failure requiring dialysis
Associated procedures (+/- Coranary Artery Bipass Graft (CABG))
Endocarditis
Re-operation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After patient suitability is confirmed and informed consent is obtained, pre-operative data will be entered into the database and it will generate a randomization statement (either ‘tissue valve’ or ‘mechanical valve’). Allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence is generated by computerized random number generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4772 0
Charities/Societies/Foundations
Name [1] 4772 0
Princess Alexandra Hospital (PAH) Private Practice Trust Fund: Research Support Grant
Country [1] 4772 0
Australia
Funding source category [2] 4773 0
Commercial sector/Industry
Name [2] 4773 0
Medtronic Australia. Pty LTD.
Country [2] 4773 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
PAH Private Practice Trust Fund: Research Support Grant
Address
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 4311 0
Commercial sector/Industry
Name [1] 4311 0
Medtronic Australia. Pty LTD.
Address [1] 4311 0
Level 3, 57 Coronation Drive
Brisbane, QLD 4000
Country [1] 4311 0
Australia
Other collaborator category [1] 641 0
Hospital
Name [1] 641 0
Princess Alexandra Hospital
Address [1] 641 0
199 Ipswich Road
Woolloongabba
QLD 4102
Country [1] 641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6820 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 6820 0
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba
Queensland 4102
Ethics committee country [1] 6820 0
Australia
Date submitted for ethics approval [1] 6820 0
Approval date [1] 6820 0
09/02/2009
Ethics approval number [1] 6820 0
2008/244

Summary
Brief summary
In this study, we will seek whether there is any difference in valve related complications (MAPE: major adverse postoperative events i.e. reoperation, endocarditis, major bleeding or thromboembolism ) and short/long term survival between patients receiving tissue vs mechanical valves. It will be a prospective randomized study using the two most commonly used valves - St Jude Mechanical (St Jude Medical) and Mosaic tissue (Medtronic).

Patients requiring aortic valve replacement who give consent will be randomized to either having tissue or mechanical valves. They will undergo echocardiogram and quality of life measures at baseline. They will be followed up during their stay in hospital and periodically thereafter to gather data to obtain the information described below. They will receive an echocardiogram at 6 months, 24 months and ever 24 months thereafter until the end of follow up (up to ten years). They will also receive telephone interview six monthly but the research assistants and yearly by the clinicians. Data will be gathered to identify the following:

1] Predictors of early and late mortality
2] Long term survival
2] Freedom from reoperation
3] Freedom from TIA, stroke and thromboembolic episodes
4] Freedom from endocarditis
5] Freedom from hemorrhagic complications
6] Freedom from hospitalization
7] Rate of readmission
8] Freedom from valve failure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29479 0
Address 29479 0
Country 29479 0
Phone 29479 0
Fax 29479 0
Email 29479 0
Contact person for public queries
Name 12726 0
Pallav Shah
Address 12726 0
Department of Cardiothoracic Surgery
Princess Alexandra Hospital
Ipswich Road
Wooloongabba
QLD 4102
Country 12726 0
Australia
Phone 12726 0
+617 3240 2071
Fax 12726 0
+617 3240 6954
Email 12726 0
Pallav_Shah@health.qld.gov.au
Contact person for scientific queries
Name 3654 0
Pallav Shah
Address 3654 0
Department of Cardiothoracic Surgery
Princess Alexandra Hospital
Ipswich Road
Country 3654 0
Australia
Phone 3654 0
+617 3240 2071
Fax 3654 0
+617 3240 6954
Email 3654 0
Pallav_Shah@health.qld.gov.au

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
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Documents added automatically
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