Condition or disease | Intervention/treatment | Phase |
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Aortic Valve Stenosis Limited Access Aortic Valve Replacement Quality of Life | Procedure: Limited access aortic valve replacement. Procedure: Conventional aortic valve replacement | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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Active Comparator: Conventional group
All patients undergoing aortic valve replacement through full sternotomy.
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Procedure: Conventional aortic valve replacement
Aortic valve replacement through full median sternotomy
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Experimental: Limited access group
All patients undergoing aortic valve replacement through partial upper hemisternotomy.
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Procedure: Limited access aortic valve replacement.
Limited access aortic valve replacement through partial upper hemisternotomy
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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
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:
Exclusion Criteria:
Netherlands | |
St Antonius Ziekenhuis | |
Nieuwegein, Utrecht, Netherlands, 3435CM |
Tracking Information | |||||
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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 |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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. |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
161 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |