The aim of this study is to compare health status, quality of life outcomes and subjective postoperative pain for patients with severe aortic stenosis treated either with a limited access aortic valve replacement or with a conventional aortic valve…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Limited access aortic valve replacement leads to short-term advantage in both
improvement in health status and reduced postoperative pain compared to
conventional aortic valve replacement. This leads to early mobilization and
faster recovery. The use of sutureless valves as a part of limited access
cardiac surgery further enhances these beneficial effects, leading to a better
and faster recovery postoperatively.
Study objective
The aim of this study is to compare health status, quality of life outcomes and
subjective postoperative pain for patients with severe aortic stenosis treated
either with a limited access aortic valve replacement or with a conventional
aortic valve replacement.
Study design
The LIAR-Trial is a single-centre randomised controlled trial to aim for
improved health status and reduced pain postoperatively by using a
ministernotomy for the placement of a sutureless aortic valve, compared to the
placement of a sutureless aortic valve through the conventional full
sternotomy.
Intervention
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 groups will receive a sutureless
valve.
Study burden and risks
The risks associated with participation in the trial concerning the limited
access approach are comparable with the conventional approach. Furthermore, it
has been demonstrated that the addition of a sutureless valve is feasible with
good efficacy and safety. The burden for patients is also very low. They have
to fill in two questionnaires at baseline, and postoperative pain sensation
every day during their hospital length. During follow-up they have to fill in
the two questionnaires and pain sensation four times during the first year.
Five years after surgery we will ask the patients to fill out the quality of
life questionnaires. Furthermore, we will evaluate the postoperative survival
five years after surgery. Patients will receive an ultrasound of the heart
according to regular practice and in accordance with the cardiologist.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing an aortic valve replacement for an aortic valve stenosis,
defined as:
o An aortic valve area of <1.0cm2, and;
o Mean valve gradient of 40mmHg, and/or;
o A peak velocity of a least 4.0m/s.
- Able to understand the nature of the study and what will be required of them;
- All men and non-pregnant woman;
- BMI between 18-35.
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 (<90 days);
- Recent stroke or transient ischemic attack (<6 months);
- Participation in a different heart-surgery related trial.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56311.100.16 |