An interventional study of ministernotomy and Full sternotomy in Aortic Valve Stenosis, Heart Valve Diseases and Aortic Valve Disease, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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).
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 96 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Minimally invasive aortic valve replacement with Partial "J" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice.
Procedure: ministernotomy
Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.
Procedure: Full sternotomy
Partial upper "J" hemisternotomy trough 4th right intercostal space)
Conventional full median sternotomy
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
Time frame: baseline-1-6-12 months
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
Time frame: 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
Time frame: 1 month
Satiscore Questionnaire
Satisfaction in cardiac surgery
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
Questionnaire EQ-5D-5L® for quality of life
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
Questionnaire EQ-5D-5L® for quality of life
Time frame: 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
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
To assess heart failure status between participants
Time frame: baseline-1-6-12 months
Number of participants alive (Survival)
To assess first year mortality
Time frame: 6-12 months
Number of participants alive (Survival)
To assess 5 year mortality
Time frame: 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,
Time frame: 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,
Time frame: 1-5 years year
Plan to share: No
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud