NCT02726087

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

March 13, 2016

Last Update Submit

February 3, 2020

Conditions

Aortic Valve StenosisHeart Valve DiseasesAortic Valve Disease

Keywords

Ministernotomyaortic valve stenosisquality of lifesatisfactioncardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    baseline-1-6-12 months

  • Early postoperative combined endpoint of 6 complications

    1 month

  • Satiscore Questionnaire

    1-6 months

  • Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months

    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

    baseline-1-6-12 months

  • +10 more secondary outcomes

Study Arms (2)

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.

Procedure: ministernotomy

full sternotomy

ACTIVE COMPARATOR

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

Procedure: Full sternotomy

Interventions

ministernotomyPROCEDURE

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

ministernotomy
Full sternotomyPROCEDURE

Conventional full median sternotomy

full sternotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29454380DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve DiseasesAortic Valve DiseasePersonal Satisfaction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionBehavior

Study Officials

  • Emiliano A Rodriguez-Caulo, MD,PhD,FECTS

    Hospital Universitario Virgen de la Victoria, Málaga, spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FETCS

Study Record Dates

First Submitted

March 13, 2016

First Posted

April 1, 2016

Study Start

March 20, 2016

Primary Completion

May 20, 2019

Study Completion

October 20, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)