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

NCT ID: NCT04012060

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-13
• Study Completion Date: 2020-07-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional group

All patients undergoing aortic valve replacement through full sternotomy.

Group Type: ACTIVE_COMPARATOR

Conventional aortic valve replacement

Intervention Type: PROCEDURE

Aortic valve replacement through full median sternotomy

Limited access group

All patients undergoing aortic valve replacement through partial upper hemisternotomy.

Group Type: EXPERIMENTAL

Limited access aortic valve replacement.

Intervention Type: PROCEDURE

Limited access aortic valve replacement through partial upper hemisternotomy

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.

Group Type: OTHER

Conventional aortic valve replacement

Intervention Type: PROCEDURE

Aortic valve replacement through full median sternotomy

Interventions

Limited access aortic valve replacement.

Limited access aortic valve replacement through partial upper hemisternotomy

Intervention Type: PROCEDURE

Conventional aortic valve replacement

Aortic valve replacement through full median sternotomy

Intervention Type: PROCEDURE

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);

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Idserd Klop

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

References

Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3.

Reference Type: DERIVED

PMID: 38054555 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33506139 (View on PubMed)

Other Identifiers

NL56311.100.16

Identifier Type: -

Identifier Source: org_study_id