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

NCT04012060 | Completed

• 1 other identifier: NL56311.100.16
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Changes in cardiac-specific quality of life after aortic valve replacement.

  Change in cardiac specific quality of life after aortic valve replacement measured by the physical limitations and symptoms domains from the Kansas City Cardiomyopathy Questionnaire (KCCQ).

  One, three, six and twelve months after surgery

Secondary Outcomes (14)

• Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  One, three, six and twelve months after surgery

• Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  One, three, six and twelve months after surgery

• Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  One, three, six and twelve months after surgery

• Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36).

  One, three, six and twelve months after surgery

• Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36).

  One, three, six and twelve months after surgery

Study Arms (3)

Conventional group

ACTIVE COMPARATOR

All patients undergoing aortic valve replacement through full sternotomy.

Procedure: Conventional aortic valve replacement

Limited access group

EXPERIMENTAL

All patients undergoing aortic valve replacement through partial upper hemisternotomy.

Procedure: Limited access aortic valve replacement.

Registry group

OTHER

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.

Procedure: Conventional aortic valve replacement

Interventions

Limited access aortic valve replacement. PROCEDURE

Limited access aortic valve replacement through partial upper hemisternotomy

Limited access group

Conventional aortic valve replacement PROCEDURE

Aortic valve replacement through full median sternotomy

Conventional group; Registry group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 38054555 DERIVED

• 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.

  PMID: 33506139 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients randomized to either the limited access or conventional aortic valve replacement will be blinded for the treatment until day four postoperatively. The patients participating in the prospective registry will not be blinded for their treatment. All nurses on the postoperative ward are blinded for the treatment the patients received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: June 13, 2016
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)