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Prospective randomized study to determine the clinical outcomes of tissue and mechanical aortic valve replacement in patients aged 55-70yrs.

Prospective randomized study to determine the clinical outcomes of tissue and mechanical aortic valve replacement in patients aged 55-70yrs.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000303246
Enrollment
220
Registered
2009-05-19
Start date
2009-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Sponsors

PAH Private Practice Trust Fund: Research Support Grant
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
55 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients requiring Aortic Valve Replacement in the age group 55-70.

Exclusion criteria

Non-english speaking Contraindication to anticoagulation Renal failure requiring dialysis Associated procedures (+/- Coranary Artery Bipass Graft (CABG)) Endocarditis Re-operation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026