Status:
COMPLETED
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
Lead Sponsor:
St. Antonius Hospital
Conditions:
Aortic Valve Stenosis
Limited Access Aortic Valve Replacement
Eligibility:
All Genders
Phase:
NA
Brief Summary
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a ...
Detailed Description
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a ...
Eligibility Criteria
Inclusion
- Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:
- An aortic valve area of ≤1.0cm2, and;
- Mean valve gradient ≥40mmHg, and/or;
- A peak velocity of at least 4.0m/s.
- Able to understand the nature of the study and what will be required of them;
- All adult men and non-pregnant women;
- BMI between 18-35.
Exclusion
- Inability to give written informed consent;
- Inability to adequately answer the questionnaires;
- Patients requiring additional cardiac surgery during the same procedure;
- Patients requiring a reoperation;
- (relative) contraindications for a limited access approach;
- Undergoing an emergency operation;
- Recent myocardial infarction (\<90 days);
- Recent stroke or transient ischemic attack (\<6 months);
Key Trial Info
Start Date :
June 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04012060
Start Date
June 13 2016
End Date
July 7 2020
Last Update
May 13 2021
Active Locations (1)
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1
St Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3435CM