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Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

NCT02726087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-02-05

No results posted yet for this study

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).

Conditions

  • Aortic Valve Stenosis
  • Heart Valve Diseases
  • Aortic Valve Disease

Interventions

PROCEDURE

ministernotomy

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

PROCEDURE

Full sternotomy

Conventional full median sternotomy

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Emiliano A Rodriguez-Caulo, MD,PhD,FECTS · Hospital Universitario Virgen de la Victoria, Málaga, spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-20
Primary Completion
2019-05-20
Completion
2019-10-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726087 on ClinicalTrials.gov