Clinical trial NCT04012060: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Limited Access Aortic Valve Replacement
Quality of Life
Keywords: Limited access
Aortic valve replacement
upper hemisternotomy
patient reported outcomes
randomized clinical trial
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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);

Primary outcomes:
measure: Changes in cardiac-specific quality of life after aortic valve replacement.
timeFrame: One, three, six and twelve months after surgery
Secondary outcomes:
measure: Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: One, three, six and twelve months after surgery
measure: Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: One, three, six and twelve months after surgery
measure: Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: One, three, six and twelve months after surgery
measure: Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36).
timeFrame: One, three, six and twelve months after surgery
measure: Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36).
timeFrame: One, three, six and twelve months after surgery
measure: Postoperative sternal pain
timeFrame: First seven days after surgery and one, three, six and twelve months after surgery
measure: Perioperative outcomes
timeFrame: During surgery
measure: Clinical outcomes
timeFrame: Up to one year postoperatively.
measure: Technicall success rate of the aortic valve replacement.
timeFrame: During surgery (peri-operatively)
measure: Hospital length of stay
timeFrame: Up to one year postoperatively
measure: Intensive Care length of stay
timeFrame: Up to one year postoperatively
measure: Effective orifice area of the aortic valve prosthesis
timeFrame: Up to one year postoperatively
measure: Need of analgetic drugs
timeFrame: Up to one year postoperatively
measure: Mean pressure gradient of the aortic valve prosthesis.
timeFrame: Up to one year postoperatively
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
state: Utrecht
Study officials:
References:
citation: Klop IDG, van Putte BP, Kloppenburg GTL, Sprangers MAG, Nieuwkerk PT, Klein P. Comparing quality of life and postoperative pain after limited access and conventional aortic valve replacement: Design and rationale of the LImited access aortic valve replacement (LIAR) trial. Contemp Clin Trials Commun. 2021 Jan 12;21:100700. doi: 10.1016/j.conctc.2021.100700. eCollection 2021 Mar.