- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012060
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement (LIAR)
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utrecht
-
Nieuwegein, Utrecht, Netherlands, 3435CM
- St Antonius Ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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);
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional group
All patients undergoing aortic valve replacement through full sternotomy.
|
Aortic valve replacement through full median sternotomy
|
EXPERIMENTAL: Limited access group
All patients undergoing aortic valve replacement through partial upper hemisternotomy.
|
Limited access aortic valve replacement through partial upper hemisternotomy
|
OTHER: Registry group
All patients unwilling or unable to participate in the randomized part of the trial. All patients will undergo aortic valve replacement through median full sternotomy. |
Aortic valve replacement through full median sternotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cardiac-specific quality of life after aortic valve replacement.
Time Frame: One, three, six and twelve months after surgery
|
Change in cardiac specific quality of life after aortic valve replacement measured by the physical limitations and symptoms domains from the Kansas City Cardiomyopathy Questionnaire (KCCQ).
|
One, three, six and twelve months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: One, three, six and twelve months after surgery
|
Changes in the self-efficacy domain of the KCCQ, after aortic valve replacement.
|
One, three, six and twelve months after surgery
|
Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: One, three, six and twelve months after surgery
|
Changes in social interference domain of the KCCQ, after aortic valve replacement.
|
One, three, six and twelve months after surgery
|
Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: One, three, six and twelve months after surgery
|
Changes in quality of life domain of the KCCQ, after aortic valve replacement.
|
One, three, six and twelve months after surgery
|
Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36).
Time Frame: One, three, six and twelve months after surgery
|
The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health.
These domains can be combined into the PCS and MCS.
|
One, three, six and twelve months after surgery
|
Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36).
Time Frame: One, three, six and twelve months after surgery
|
The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health.
These domains can be combined into the PCS and MCS.
|
One, three, six and twelve months after surgery
|
Postoperative sternal pain
Time Frame: First seven days after surgery and one, three, six and twelve months after surgery
|
Assessed with a visual analogue score.
The VAS is depicted as a straight line from left to right and ranges from 0 (no pain) to 100 (worst imaginable pain)
|
First seven days after surgery and one, three, six and twelve months after surgery
|
Perioperative outcomes
Time Frame: During surgery
|
aortic cross clamp time (minutes), cardio-pulmonary bypass time (minutes), operating time (minutes) are the main focus.
All three outcomes will be measured in minutes.
|
During surgery
|
Clinical outcomes
Time Frame: Up to one year postoperatively.
|
30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate
|
Up to one year postoperatively.
|
Technicall success rate of the aortic valve replacement.
Time Frame: During surgery (peri-operatively)
|
Technical success rate is defined as a limited access approach without conversion and placement of the rapid deployment bioprosthesis
|
During surgery (peri-operatively)
|
Hospital length of stay
Time Frame: Up to one year postoperatively
|
The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)
|
Up to one year postoperatively
|
Intensive Care length of stay
Time Frame: Up to one year postoperatively
|
The hours a patient has to stay in the Intensive Care Unit postoperatively
|
Up to one year postoperatively
|
Effective orifice area of the aortic valve prosthesis
Time Frame: Up to one year postoperatively
|
Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured.
A transthoracic echocardiography will be made during follow-up.
The effective orifice area, in square centimeters (cm^2), will be measured.
|
Up to one year postoperatively
|
Need of analgetic drugs
Time Frame: Up to one year postoperatively
|
The intake of analgesic drugs (paracetamol and morfine) will be measured.
|
Up to one year postoperatively
|
Mean pressure gradient of the aortic valve prosthesis.
Time Frame: Up to one year postoperatively
|
Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured.
A transthoracic echocardiography will be made during follow-up.
The mean pressure gradients in milimeters of mercury (mmHg) will be measured.
|
Up to one year postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL56311.100.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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