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The Liar-Trial: patient reported health-related quality of life after LImited access and conventional Aortic valve Replacement.

The Liar-Trial: patient reported health-related quality of life after LImited access and conventional Aortic valve Replacement. - LIAR-Trial (LImited access Aortic valve Replacement-Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55420
Enrollment
160
Registered
2016-06-13
Start date
2016-06-29
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

aortic valve stenosis heart valve restriction

Interventions

The intervention group will undergo a limited acces aortic valve replacement through ministernotomy, while the control group will undergo an aortic valve replacement through full sternotomy. Both gr

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients undergoing an aortic valve replacement for an aortic valve stenosis, defined as: o An aortic valve area of

Exclusion criteria

Exclusion criteria: - Inability to give written informed consent; - Patients requiring additional cardiac surgery during the same procedure; - Patients requiring a reoperation (of the aortic valve); - (relative) contraindications for a limited access approach; - Undergoing an emergency operation; - Recent myocardial infarction (

Design outcomes

Primary

MeasureTime frame
The main objective of the LIAR-Trial is to provide evidence on improving health status, quality of life and postoperative pain sensation after limited access aortic valve surgery, measured by multiple validated health questionnaires.

Secondary

MeasureTime frame
Secondary objectives are aortic cross clamping time, cardio pulmonary bypass time, total operating time, technical success rate, complication rate, mortality rate, hospital length of stay, intensive care unit stay, reoperation rate, readmission rate and haemodynamic performance.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)