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

St. Antonius Hospital

Status: Completed

Conditions: Limited Access Aortic Valve Replacement; Aortic Valve Stenosis; Quality of Life

Treatments: Procedure: Limited access aortic valve replacement.; Procedure: Conventional aortic valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04012060

NL56311.100.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 3 patient groups

Conventional group

Active Comparator group

Description:

All patients undergoing aortic valve replacement through full sternotomy.

Treatment:

Procedure: Conventional aortic valve replacement

Limited access group

Experimental group

Description:

All patients undergoing aortic valve replacement through partial upper hemisternotomy.

Treatment:

Procedure: Limited access aortic valve replacement.

Registry group

Other group

Description:

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.

Treatment:

Procedure: Conventional aortic valve replacement