Brief Title
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
Official Title
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.
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 full median sternotomy (FMS). Primary outcome is cardiac-specific
quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire
(KCCQ), up to one year after surgery.
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 full median sternotomy (FMS). To reduce potential confounding by
differences in implanted valve prostheses, in both arms of the trail, the diseased native
aortic valve is planned to be replaced with a rapid deployment stented aortic bioprosthesis
(Edwards Intuity Elite Valve System®, Edwards Lifesciences Corporation), the preferred type
of valve prosthesis for a limited access approach. Patients will be randomized 1:1 to both
arms with 80 patients per arm. Patients who are unwilling or unable to participate in the
randomized study will be treated via conventional median sternotomy with a sutured aortic
valve prosthesis and participate in a prospective registry.
Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas
City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery. Secondary outcomes
include, but are not limited to: generic quality of life measured with the Short Form-36
(SF-36), postoperative pain, perioperative outcome (i.e. technical success rate, operating
time) and postoperative outcome (i.e. 30 day and one-year mortality, complication rate,
hospital length of stay, reoperation rate and readmission rate). Questionnaires are
administered face to face or by telephone prior to surgery and at one, three, six and twelve
months after surgery. In the prospective registry the quality of life questionnaires and all
clinical data from the patients will be collected and analyzed the exact same way as the data
from patients included and randomized in the trial.
Study Type
Interventional
Primary Outcome
Changes in cardiac-specific quality of life after aortic valve replacement.
Secondary Outcome
Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Condition
Aortic Valve Stenosis
Intervention
Limited access aortic valve replacement.
Study Arms / Comparison Groups
Conventional group
Description: All patients undergoing aortic valve replacement through full sternotomy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
160
Start Date
June 13, 2016
Completion Date
July 7, 2020
Primary Completion Date
July 7, 2020
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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);
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04012060
Organization ID
NL56311.100.16
Responsible Party
Principal Investigator
Study Sponsor
St. Antonius Hospital
Study Sponsor
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Verification Date
July 2019