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

Quality of Life Clinical Trial

— LIAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012060
• Other study ID #: NL56311.100.16
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: July 7, 2020

Study information

• Verified date: May 2021
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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);

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Limited access aortic valve replacement.
Limited access aortic valve replacement through partial upper hemisternotomy
• Conventional aortic valve replacement
Aortic valve replacement through full median sternotomy

Locations

Country	Name	City	State
Netherlands	St Antonius Ziekenhuis	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Changes in the self-efficacy domain of the KCCQ, after aortic valve replacement.	One, three, six and twelve months after surgery
Secondary	Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Changes in social interference domain of the KCCQ, after aortic valve replacement.	One, three, six and twelve months after surgery
Secondary	Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Changes in quality of life domain of the KCCQ, after aortic valve replacement.	One, three, six and twelve months after surgery
Secondary	Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36).	The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health. These domains can be combined into the PCS and MCS.	One, three, six and twelve months after surgery
Secondary	Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36).	The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health. These domains can be combined into the PCS and MCS.	One, three, six and twelve months after surgery
Secondary	Postoperative sternal pain	Assessed with a visual analogue score. The VAS is depicted as a straight line from left to right and ranges from 0 (no pain) to 100 (worst imaginable pain)	First seven days after surgery and one, three, six and twelve months after surgery
Secondary	Perioperative outcomes	aortic cross clamp time (minutes), cardio-pulmonary bypass time (minutes), operating time (minutes) are the main focus. All three outcomes will be measured in minutes.	During surgery
Secondary	Clinical outcomes	30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate	Up to one year postoperatively.
Secondary	Technicall success rate of the aortic valve replacement.	Technical success rate is defined as a limited access approach without conversion and placement of the rapid deployment bioprosthesis	During surgery (peri-operatively)
Secondary	Hospital length of stay	The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)	Up to one year postoperatively
Secondary	Intensive Care length of stay	The hours a patient has to stay in the Intensive Care Unit postoperatively	Up to one year postoperatively
Secondary	Effective orifice area of the aortic valve prosthesis	Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured. A transthoracic echocardiography will be made during follow-up. The effective orifice area, in square centimeters (cm^2), will be measured.	Up to one year postoperatively
Secondary	Need of analgetic drugs	The intake of analgesic drugs (paracetamol and morfine) will be measured.	Up to one year postoperatively
Secondary	Mean pressure gradient of the aortic valve prosthesis.	Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured. A transthoracic echocardiography will be made during follow-up. The mean pressure gradients in milimeters of mercury (mmHg) will be measured.	Up to one year postoperatively