Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

NCT ID: NCT02726087

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-20
• Study Completion Date: 2019-10-20

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).

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.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ministernotomy

Minimally invasive aortic valve replacement with Partial "J" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice.

Group Type: EXPERIMENTAL

ministernotomy

Intervention Type: PROCEDURE

Partial upper "J" hemisternotomy trough 4th right intercostal space)

full sternotomy

Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.

Group Type: ACTIVE_COMPARATOR

Full sternotomy

Intervention Type: PROCEDURE

Conventional full median sternotomy

Interventions

ministernotomy

Partial upper "J" hemisternotomy trough 4th right intercostal space)

Intervention Type: PROCEDURE

Full sternotomy

Conventional full median sternotomy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Emiliano Rodriguez-Caulo

MD, PhD, FETCS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emiliano A Rodriguez-Caulo, MD,PhD,FECTS

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Victoria, Málaga, spain

Locations

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 29454380 (View on PubMed)

Other Identifiers

CALIDAD-SVAO

Identifier Type: -

Identifier Source: org_study_id