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Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement (QUALITY-AVR)

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ClinicalTrials.gov Identifier: NCT02726087
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Emiliano Rodriguez-Caulo, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Aortic Valve Disease Procedure: ministernotomy Procedure: Full sternotomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : March 20, 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ministernotomy
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
Partial upper "J" hemisternotomy trough 4th right intercostal space)

Active Comparator: full sternotomy
Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.
Procedure: Full sternotomy
Conventional full median sternotomy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Questionnaire EQ-5D-5L® for quality of life

  2. Early postoperative combined endpoint of 6 complications [ Time Frame: 1 month ]
    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

  3. Satiscore Questionnaire [ Time Frame: 1-6 months ]
    Satisfaction in cardiac surgery

  4. 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 ]
    Questionnaire EQ-5D-5L® for quality of life

  5. 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 ]
    Questionnaire EQ-5D-5L® for quality of life

  6. Late postoperative combined endpoint of 6 complications [ Time Frame: 1-5 years ]
    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

  7. 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 ]
  8. Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery [ Time Frame: day 1 after surgery ]
  9. Mechanical Ventilatory Support time needed after surgery (in hours) [ Time Frame: 7 days ]
  10. Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets) [ Time Frame: First 72 hours after surgery ]
  11. New York Heart Association functional class scale for heart failure [ Time Frame: baseline-1-6-12 months ]
    To assess heart failure status between participants

  12. Number of participants alive (Survival) [ Time Frame: 6-12 months ]
    To assess first year mortality

  13. Number of participants alive (Survival) [ Time Frame: 5 years ]
    To assess 5 year mortality

  14. Early postoperative combined endpoint of 4 complications [ Time Frame: 1 month ]
    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,

  15. Late postoperative combined endpoint of 4 complications [ Time Frame: 1-5 years year ]
    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,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726087


Contacts
Contact: Emiliano A Rodriguez-Caulo, MD,PhD,FECTS +34 951032054 erodriguezcaulo@hotmail.com

Locations
Spain
Hospital Universitario Virgen de La Victoria Recruiting
Malaga, Spain, 29010
Contact: Emiliano A Rodriguez-Caulo, MD,PhD,FETCS    +34 951032054    erodriguezcaulo@hotmail.com   
Principal Investigator: Emiliano A Rodríguez-Caulo, MD,PhD,FETCS         
Sub-Investigator: Juan Otero, MD, PhD         
Sub-Investigator: María José Mataró, MD, PhD         
Sub-Investigator: Gemma Sánchez-Espín, MD, PhD         
Sub-Investigator: Carlos Porras, MD         
Sub-Investigator: Miguel Such, MD,PhD,FETCS         
Sub-Investigator: Ana Guijarro, MD         
Sub-Investigator: José María Melero, MD, FETCS         
Sub-Investigator: José M Villaescusa, MD         
Sub-Investigator: Begoña Vidal, MD         
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
Principal Investigator: Emiliano A Rodriguez-Caulo, MD,PhD,FECTS Hospital Universitario Virgen de la Victoria, Málaga, spain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emiliano Rodriguez-Caulo, MD, PhD, FETCS, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02726087     History of Changes
Other Study ID Numbers: CALIDAD-SVAO
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Emiliano Rodriguez-Caulo, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Ministernotomy
aortic valve stenosis
quality of life
satisfaction
cardiac surgery

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction