Aortic Valve StenosisQUALITY-AVRNCT02726087
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
A study testing ministernotomy and Full sternotomy in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- What is being tested?
- ministernotomy and Full sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2016to 20 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 or mean gradient greater than 40 mmHg by echocardiography or double lesion with predominant stenosis.
- Referred for medically indicated aortic valve replacement
- Provide written informed consent
Who cannot join
- Left ventricular ejection fraction less than 0.40
- Presence of any coexisting severe valvular disorder
- Previous cardiac surgery
- Urgent or emergent surgery
- Infective endocarditis
- Need for concomitant procedures other than isolated myectomy
- Severe COPD
- Severe thorax deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).
Read the detailed description
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale.
Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement due to aortic stenosis in patients >18 years.
Exclusion criteria are left ventricular ejection fraction less than 40%, previous cardiac surgery, urgent/emergent surgery, infective endocarditis, need of concomitant procedures other than isolated Morrow miectomy and thorax deformity.
CE-marked and FDA-approved mechanical (Sorin Carbomedics®) and stented bioprosthetic aortic valves will be implanted (Carpentier Edwards Perimount® and Sorin Crown®). Perceval S Sutureless bioprosthetic valves (LivaNova®) could be used if needed in very small aortic annulus or high risk patients Quality of Life postoperative outcomes will be assessed, as QOL measurements and health status with the EQ-5D-5L® questionnaire (QOL index, health visual analogic scale, severity index and health index), repeatedly assessed preoperatively and postoperatively at 1-6-12 months. Clinical postoperative complications and outcomes will be registered at 1 month and 1 year as main secondary and safety end-point (combined end-point of 4 and 6 major complications) Patient Satisfaction will be assessed with a 20 question cardiac-surgery specific satisfaction questionnaire (SATISCORE®).
Survival will be assessed at 1 year. Clinical pre and postoperative characteristics will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent) will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
The Institutional Review Board Ethic Comittee approved this study.
- Being tested
- ministernotomy, Full sternotomy
- Keywords
- Ministernotomy, aortic valve stenosis, quality of life, satisfaction, cardiac surgery
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ministernotomyProcedure or surgery
Partial upper "J" hemisternotomy trough 4th right intercostal space)
Full sternotomyProcedure or surgery
Conventional full median sternotomy
| Study group | Role | What they receive |
|---|---|---|
| ministernotomy | Experimental | Minimally invasive aortic valve replacement with Partial "J" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice. Receives: Procedure: ministernotomy |
| full sternotomy | Active comparator | Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice. Receives: Procedure: Full sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months
Questionnaire EQ-5D-5L® for quality of life
Measured: baseline-1-6-12 months
Secondary outcomes (15)
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Visual Analogic Scale for pain at 1, 6 or 12 months
Questionnaire EQ-5D-5L® for quality of life
Measured: baseline-1-6-12 months
Early postoperative combined endpoint of 6 complications
All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention
Measured: 1 month
Satiscore Questionnaire
Satisfaction in cardiac surgery
Measured: 1-6 months
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months
Questionnaire EQ-5D-5L® for quality of life
Measured: baseline-1-6-12 months
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® health index (severity index inverse) at 1, 6 and 12 months
Questionnaire EQ-5D-5L® for quality of life
Measured: baseline-1-6-12 months
Late postoperative combined endpoint of 6 complications
All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention
Measured: 1-5 years
Total in-Hospital and Intensive Care Unit stay (in days)
Measured: From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery
Measured: day 1 after surgery
Mechanical Ventilatory Support time needed after surgery (in hours)
Measured: 7 days
Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
Measured: First 72 hours after surgery
New York Heart Association functional class scale for heart failure
To assess heart failure status between participants
Measured: baseline-1-6-12 months
Number of participants alive (Survival)
To assess first year mortality
Measured: 6-12 months
Number of participants alive (Survival)
To assess 5 year mortality
Measured: 5 years
Early postoperative combined endpoint of 4 complications
All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2,
Measured: 1 month
Late postoperative combined endpoint of 4 complications
All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2,
Measured: 1-5 years year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start20 Mar 2016
- Primary completion20 May 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Rodriguez-Caulo, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Investigators
- Emiliano A Rodriguez-Caulo, MD,PhD,FECTS, Principal investigator, Hospital Universitario Virgen de la Victoria, Málaga, spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726087
- Sponsor's protocol ID
- CALIDAD-SVAO
- Acronym
- QUALITY-AVR
- Status last verified
- Feb 2020
- First submitted
- 13 Mar 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rodriguez-Caulo EA, Guijarro-Contreras A, Otero-Forero J, Mataro MJ, Sanchez-Espin G, Guzon A, Porras C, Such M, Ordonez A, Melero-Tejedor JM, Jimenez-Navarro M. Quality of life, satisfaction and outcomes after ministernotomy versus full sternotomy isolated aortic valve replacement (QUALITY-AVR): study protocol for a randomised controlled trial. Trials. 2018 Feb 17;19(1):114. doi: 10.1186/s13063-018-2486-x.
PubMed 29454380
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)
- ClinicalTrials.gov ID
- NCT02726087
- Acronym / sponsor ID
- QUALITY-AVR / CALIDAD-SVAO
- Keywords
- Ministernotomy, aortic valve stenosis, quality of life, satisfaction, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 20 Mar 2016
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).
Detailed description
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale.
Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement due to aortic stenosis in patients >18 years.
Exclusion criteria are left ventricular ejection fraction less than 40%, previous cardiac surgery, urgent/emergent surgery, infective endocarditis, need of concomitant procedures other than isolated Morrow miectomy and thorax deformity.
CE-marked and FDA-approved mechanical (Sorin Carbomedics®) and stented bioprosthetic aortic valves will be implanted (Carpentier Edwards Perimount® and Sorin Crown®). Perceval S Sutureless bioprosthetic valves (LivaNova®) could be used if needed in very small aortic annulus or high risk patients Quality of Life postoperative outcomes will be assessed, as QOL measurements and health status with the EQ-5D-5L® questionnaire (QOL index, health visual analogic scale, severity index and health index), repeatedly assessed preoperatively and postoperatively at 1-6-12 months. Clinical postoperative complications and outcomes will be registered at 1 month and 1 year as main secondary and safety end-point (combined end-point of 4 and 6 major complications) Patient Satisfaction will be assessed with a 20 question cardiac-surgery specific satisfaction questionnaire (SATISCORE®).
Survival will be assessed at 1 year. Clinical pre and postoperative characteristics will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent) will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
The Institutional Review Board Ethic Comittee approved this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ministernotomy | Experimental | Procedure: ministernotomyMinimally invasive aortic valve replacement with Partial "J" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice. |
| full sternotomy | Active comparator | Procedure: Full sternotomyFull sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 or mean gradient greater than 40 mmHg by echocardiography or double lesion with predominant stenosis.
- Referred for medically indicated aortic valve replacement
- Provide written informed consent
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction less than 0.40
- Presence of any coexisting severe valvular disorder
- Previous cardiac surgery
- Urgent or emergent surgery
- Infective endocarditis
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 |
|---|---|---|
| ministernotomyPartial upper "J" hemisternotomy trough 4th right intercostal space) | Procedure or surgery | ministernotomy |
| Full sternotomyConventional full median sternotomy | Procedure or surgery | full sternotomy |
Primary outcome
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months
Time frame: baseline-1-6-12 months
Questionnaire EQ-5D-5L® for quality of life
15 secondary outcomes
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Visual Analogic Scale for pain at 1, 6 or 12 months
Time frame: baseline-1-6-12 months
Early postoperative combined endpoint of 6 complications
Time frame: 1 month
Satiscore Questionnaire
Time frame: 1-6 months
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months
Time frame: baseline-1-6-12 months
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® health index (severity index inverse) at 1, 6 and 12 months
Time frame: baseline-1-6-12 months
Late postoperative combined endpoint of 6 complications
Time frame: 1-5 years
Total in-Hospital and Intensive Care Unit stay (in days)
Time frame: From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery
Time frame: day 1 after surgery
Mechanical Ventilatory Support time needed after surgery (in hours)
Time frame: 7 days
Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
Time frame: First 72 hours after surgery
New York Heart Association functional class scale for heart failure
Time frame: baseline-1-6-12 months
Number of participants alive (Survival)
Time frame: 6-12 months
Number of participants alive (Survival)
Time frame: 5 years
Early postoperative combined endpoint of 4 complications
Time frame: 1 month
Late postoperative combined endpoint of 4 complications
Time frame: 1-5 years year
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 5 Feb 2020.
- Derived from this study: PubMed 29454380Rodriguez-Caulo EA, Guijarro-Contreras A, Otero-Forero J, Mataro MJ, Sanchez-Espin G, Guzon A, Porras C, Such M, Ordonez A, Melero-Tejedor JM, Jimenez-Navarro M. Quality of life, satisfaction and outcomes after ministernotomy versus full sternotomy isolated aortic valve replacement (QUALITY-AVR): study protocol for a randomised controlled trial. Trials. 2018 Feb 17;19(1):114. doi: 10.1186/s13063-018-2486-x.
- Individual participant dataSharing planned: No
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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.
Emiliano A Rodriguez-Caulo, MD,PhD,FECTS principal investigator
Hospital Universitario Virgen de la Victoria, Málaga, spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ministernotomy and Full sternotomy in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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 4 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 5 Feb 2020. 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 Spain. 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?
Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months (time frame: baseline-1-6-12 months). 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 NCT02726087, which also lists 1 linked publication.
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 5 Feb 2020.