NCT02278666

Brief Summary

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 13, 2023

Status Verified

July 1, 2022

Enrollment Period

8.1 years

First QC Date

October 27, 2014

Last Update Submit

September 11, 2023

Conditions

Aortic Valve Surgery

Outcome Measures

Primary Outcomes (3)

  • Cardiopulmonary bypass time

    during surgery

  • Total duration of Intensive Care Unit stay

    during hospital stay, usually lasting one to two weeks

  • Blood transfusions

    during hospital stay, usually lasting one to two weeks

Secondary Outcomes (7)

  • renal insufficiency

    during hospital stay, usually lasting one to two weeks

  • Prolonged ventilation

    during hospital stay

  • Re-exploration for bleeding

    during hospital stay, usually lasting one to two weeks

  • sepsis

    during hospital stay, usually lasting one to two weeks

  • Neurological complications

    during hospital stay, usually lasting one to two weeks

  • +2 more secondary outcomes

Study Arms (3)

upper mini-sternotomy

aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)

Procedure: aortic valve replacementDevice: biological prosthetic valveDevice: Mechanical valve

right mini thoracotomy

aortic valve replacement/repair surgery via right mini thoracotomy

Procedure: aortic valve replacementDevice: biological prosthetic valveDevice: Mechanical valve

conventional sternotomy

aortic valve replacement surgery via conventional full sternotomy

Procedure: aortic valve replacementDevice: biological prosthetic valveDevice: Mechanical valve

Interventions

aortic valve replacementPROCEDURE

aortic valve replacement with either biological prosthetic valve or mechanical valve

Also known as: AVR
conventional sternotomyright mini thoracotomyupper mini-sternotomy
biological prosthetic valveDEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

conventional sternotomyright mini thoracotomyupper mini-sternotomy
Mechanical valveDEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

conventional sternotomyright mini thoracotomyupper mini-sternotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing isolated aortic valve surgery

You may qualify if:

  • All patients undergoing isolated aortic valve surgery
  • Written Informed consent to the use of personal data

You may not qualify if:

  • other associated cardiac surgery
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Elisa Mikus, MD

    Maria Cecilia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

September 13, 2023

Record last verified: 2022-07

Locations

IT(1)