NCT04012060

Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement

Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Limited Access Aortic Valve Replacement
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Limited access aortic valve replacement.	Limited access aortic valve replacement through partial upper hemisternotomy
PROCEDURE	Conventional aortic valve replacement	Aortic valve replacement through full median sternotomy

Timeline

• Start date: 2016-06-13
• Primary completion: 2020-07-07
• Completion: 2020-07-07
• First posted: 2019-07-09
• Last updated: 2021-05-13

Locations

1 site across 1 country: Netherlands