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

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

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

, ,

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

, ,

Verification Date

May 2021