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出境医 / 临床实验 / Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement (LIAR)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Limited Access Aortic Valve Replacement Quality of Life Procedure: Limited access aortic valve replacement. Procedure: Conventional aortic valve replacement Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : July 7, 2020
Actual Study Completion Date : July 7, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Conventional group
All patients undergoing aortic valve replacement through full sternotomy.
Procedure: Conventional aortic valve replacement
Aortic valve replacement through full median sternotomy

Experimental: Limited access group
All patients undergoing aortic valve replacement through partial upper hemisternotomy.
Procedure: Limited access aortic valve replacement.
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.

Procedure: Conventional aortic valve replacement
Aortic valve replacement through full median sternotomy

Outcome Measures
Primary Outcome Measures :
  1. Changes in cardiac-specific quality of life after aortic valve replacement. [ Time Frame: One, three, six and twelve months after surgery ]
    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).


Secondary Outcome Measures :
  1. Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in the self-efficacy domain of the KCCQ, after aortic valve replacement.

  2. Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in social interference domain of the KCCQ, after aortic valve replacement.

  3. Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in quality of life domain of the KCCQ, after aortic valve replacement.

  4. Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36). [ Time Frame: One, three, six and twelve months after surgery ]
    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.

  5. Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36). [ Time Frame: One, three, six and twelve months after surgery ]
    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.

  6. Postoperative sternal pain [ Time Frame: First seven days after surgery and one, three, six and twelve months after surgery ]
    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)

  7. Perioperative outcomes [ Time Frame: During surgery ]
    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.

  8. Clinical outcomes [ Time Frame: Up to one year postoperatively. ]
    30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate

  9. Technicall success rate of the aortic valve replacement. [ Time Frame: During surgery (peri-operatively) ]
    Technical success rate is defined as a limited access approach without conversion and placement of the rapid deployment bioprosthesis

  10. Hospital length of stay [ Time Frame: Up to one year postoperatively ]
    The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)

  11. Intensive Care length of stay [ Time Frame: Up to one year postoperatively ]
    The hours a patient has to stay in the Intensive Care Unit postoperatively

  12. Effective orifice area of the aortic valve prosthesis [ Time Frame: Up to one year postoperatively ]
    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.

  13. Need of analgetic drugs [ Time Frame: Up to one year postoperatively ]
    The intake of analgesic drugs (paracetamol and morfine) will be measured.

  14. Mean pressure gradient of the aortic valve prosthesis. [ Time Frame: Up to one year postoperatively ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
Contacts and Locations

Locations
Layout table for location information
Netherlands
St Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3435CM
Sponsors and Collaborators
St. Antonius Hospital
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE June 13, 2016
Actual Primary Completion Date July 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Changes in cardiac-specific quality of life after aortic valve replacement. [ Time Frame: One, three, six and twelve months after surgery ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in the self-efficacy domain of the KCCQ, after aortic valve replacement.
  • Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in social interference domain of the KCCQ, after aortic valve replacement.
  • Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One, three, six and twelve months after surgery ]
    Changes in quality of life domain of the KCCQ, after aortic valve replacement.
  • Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36). [ Time Frame: One, three, six and twelve months after surgery ]
    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.
  • Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36). [ Time Frame: One, three, six and twelve months after surgery ]
    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.
  • Postoperative sternal pain [ Time Frame: First seven days after surgery and one, three, six and twelve months after surgery ]
    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)
  • Perioperative outcomes [ Time Frame: During surgery ]
    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.
  • Clinical outcomes [ Time Frame: Up to one year postoperatively. ]
    30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate
  • Technicall success rate of the aortic valve replacement. [ Time Frame: During surgery (peri-operatively) ]
    Technical success rate is defined as a limited access approach without conversion and placement of the rapid deployment bioprosthesis
  • Hospital length of stay [ Time Frame: Up to one year postoperatively ]
    The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)
  • Intensive Care length of stay [ Time Frame: Up to one year postoperatively ]
    The hours a patient has to stay in the Intensive Care Unit postoperatively
  • Effective orifice area of the aortic valve prosthesis [ Time Frame: Up to one year postoperatively ]
    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.
  • Need of analgetic drugs [ Time Frame: Up to one year postoperatively ]
    The intake of analgesic drugs (paracetamol and morfine) will be measured.
  • Mean pressure gradient of the aortic valve prosthesis. [ Time Frame: Up to one year postoperatively ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Double (Participant, Care Provider)
Masking Description:

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.

Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • Limited Access Aortic Valve Replacement
  • Quality of Life
Intervention  ICMJE
  • Procedure: Limited access aortic valve replacement.
    Limited access aortic valve replacement through partial upper hemisternotomy
  • Procedure: Conventional aortic valve replacement
    Aortic valve replacement through full median sternotomy
Study Arms  ICMJE
  • Active Comparator: Conventional group
    All patients undergoing aortic valve replacement through full sternotomy.
    Intervention: Procedure: Conventional aortic valve replacement
  • Experimental: Limited access group
    All patients undergoing aortic valve replacement through partial upper hemisternotomy.
    Intervention: Procedure: Limited access aortic valve replacement.
  • 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.

    Intervention: Procedure: Conventional aortic valve replacement
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2021)
161
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
160
Actual Study Completion Date  ICMJE July 7, 2020
Actual Primary Completion Date July 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012060
Other Study ID Numbers  ICMJE NL56311.100.16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Idserd Klop, St. Antonius Hospital
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Antonius Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP