Aortic Valve StenosisLIARNCT04012060

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

A study testing Limited access aortic valve replacement. and Conventional aortic valve replacement in people with Aortic Valve Stenosis and Limited Access Aortic Valve Replacement, run by St. Antonius Hospital at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
What is being tested?: Limited access aortic valve replacement. and Conventional aortic valve replacement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 1 siteNetherlands
Study dates: 13 Jun 2016to 7 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

St Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM

Other trials in Netherlands

About this study

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

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.

Read the 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
Being tested: Limited access aortic valve replacement., Conventional aortic valve replacement
Keywords: Limited access, Aortic valve replacement, upper hemisternotomy, patient reported outcomes, randomized clinical trial
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Limited access aortic valve replacement.Procedure or surgery
Limited access aortic valve replacement through partial upper hemisternotomy
Conventional aortic valve replacementProcedure or surgery
Aortic valve replacement through full median sternotomy

Study groups in NCT04012060
Study group	Role	What they receive
Conventional group	Active comparator	All patients undergoing aortic valve replacement through full sternotomy. Receives: Procedure: Conventional aortic valve replacement
Limited access group	Experimental	All patients undergoing aortic valve replacement through partial upper hemisternotomy. Receives: 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. Receives: Procedure: Conventional aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: One, three, six and twelve months after surgery

Secondary outcomes (14)

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.
Measured: One, three, six and twelve months after surgery
Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Changes in social interference domain of the KCCQ, after aortic valve replacement.
Measured: One, three, six and twelve months after surgery
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: One, three, six and twelve months after surgery
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)
Measured: First seven days after surgery and one, three, six and twelve months after surgery
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.
Measured: During surgery
Clinical outcomes
30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate
Measured: Up to one year postoperatively.
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
Measured: During surgery (peri-operatively)
Hospital length of stay
The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)
Measured: Up to one year postoperatively
Intensive Care length of stay
The hours a patient has to stay in the Intensive Care Unit postoperatively
Measured: Up to one year postoperatively
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.
Measured: Up to one year postoperatively
Need of analgetic drugs
The intake of analgesic drugs (paracetamol and morfine) will be measured.
Measured: Up to one year postoperatively
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.
Measured: Up to one year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 20167 Jul 2020

First posted9 Jul 2019
Study start13 Jun 2016
Primary completion7 Jul 2020
Study completion7 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04012060
Sponsor's protocol ID: NL56311.100.16
Acronym: LIAR
Status last verified: May 2021
First submitted: 2 Jul 2019
Last updated: 13 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

van Putten SE, Klop IDG, Nieuwkerk PT, Friguech B, Kloppenburg GTL, Klautz RJM, van Putte BP, Klein P. Five-Year Quality of Life Outcome From a Randomized Controlled Trial Comparing Aortic Valve Replacement Through Upper Hemisternotomy and Full Median Sternotomy. Eur J Cardiothorac Surg. 2026 Feb 5;68(2):ezag077. doi: 10.1093/ejcts/ezag077.
PubMed 41627861
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.
PubMed 38054555
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.
PubMed 33506139

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.
ClinicalTrials.gov ID: NCT04012060
Acronym / sponsor ID: LIAR / NL56311.100.16
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: St. Antonius HospitalUniversity, hospital or other
Study start: 13 Jun 2016 (actual)
Primary completion: 7 Jul 2020 (actual)
Study completion: 7 Jul 2020 (actual)
First posted: 9 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3
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.

Arm	Type	Receives
Conventional group	Active comparator	Procedure: Conventional aortic valve replacementAll patients undergoing aortic valve replacement through full sternotomy.
Limited access group	Experimental	Procedure: Limited access aortic valve replacement.All patients undergoing aortic valve replacement through partial upper hemisternotomy.
Registry group	Other	Procedure: Conventional aortic valve replacementAll patients unwilling or unable to participate in the randomized part of the trial. All patients will undergo aortic valve replacement through median full sternotomy.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:
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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Limited access aortic valve replacement.Limited access aortic valve replacement through partial upper hemisternotomy	Procedure or surgery	Limited access group
Conventional aortic valve replacementAortic valve replacement through full median sternotomy	Procedure or surgery	Conventional group, Registry group

Primary outcome

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).

14 secondary outcomes

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 social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: One, three, six and twelve months after surgery
Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 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).
Time frame: 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).
Time frame: One, three, six and twelve months after surgery
Postoperative sternal pain
Time frame: First seven days after surgery and one, three, six and twelve months after surgery
Perioperative outcomes
Time frame: During surgery
Clinical outcomes
Time frame: Up to one year postoperatively.
Technicall success rate of the aortic valve replacement.
Time frame: During surgery (peri-operatively)
Hospital length of stay
Time frame: Up to one year postoperatively
Intensive Care length of stay
Time frame: Up to one year postoperatively
Effective orifice area of the aortic valve prosthesis
Time frame: Up to one year postoperatively
Need of analgetic drugs
Time frame: Up to one year postoperatively
Mean pressure gradient of the aortic valve prosthesis.
Time frame: Up to one year postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
Derived from this study: PubMed 41627861van Putten SE, Klop IDG, Nieuwkerk PT, Friguech B, Kloppenburg GTL, Klautz RJM, van Putte BP, Klein P. Five-Year Quality of Life Outcome From a Randomized Controlled Trial Comparing Aortic Valve Replacement Through Upper Hemisternotomy and Full Median Sternotomy. Eur J Cardiothorac Surg. 2026 Feb 5;68(2):ezag077. doi: 10.1093/ejcts/ezag077.
Derived from this study: PubMed 38054555Kirmani 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.
Derived from this study: PubMed 33506139Klop 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.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cardiac-specific quality of life after aortic valve replacement. (time frame: One, three, six and twelve months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04012060, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.