NCT04632095

Brief Summary

Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

November 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

March 23, 2021

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 6, 2020

Last Update Submit

March 22, 2021

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosisminimally invasive surgeryparasternal approachquality of lifeaortic valve replacementinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Quality of life - physical function

    Comparison of the physical quality of life between the two groups 30 days after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.

    30 days after surgery

Secondary Outcomes (15)

  • Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6

    During the first 48 hours after surgery

  • Quality of Life - mental function

    30 days after surgery

  • Duration of the Operation

    During the aortic valve replacement surgery

  • Duration of cardiopulmonary bypass

    During the aortic valve replacement surgery

  • Duration of aortic clamping

    During the aortic valve replacement surgery

  • +10 more secondary outcomes

Study Arms (2)

Sternotomy AVR

ACTIVE COMPARATOR

Aortic valve replacement due to sternotomy

Procedure: Aortic valve replacement due to sternotomy

Mini AVR

ACTIVE COMPARATOR

Aortic valve replacement due to parasternal right anterior mini-thoracotomy

Procedure: Aortic valve replacement due to parasternal right anterior mini-thoracotomy

Interventions

Aortic valve replacement due to sternotomyPROCEDURE

conventional surgery of aortic stenosis

Sternotomy AVR
Aortic valve replacement due to parasternal right anterior mini-thoracotomyPROCEDURE

surgery of aortic stenosis in minimally invasive technique

Mini AVR

Eligibility Criteria

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

You may qualify if:

  • Indication for elective isolated aortic valve replacement
  • Anatomical suitability for both sternotomy and parasternal access
  • Age ≥ 18
  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

  • Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
  • Acute myocardial infarction within 4 weeks, coronary heart disease
  • Acute endocarditis
  • TIA or stroke within 6 months prior to the procedure
  • Pregnant or breast-feeding women
  • Renal failure requiring dialysis
  • Ejection fraction ≤ 30%
  • Re-operation
  • Disease with a life expectancy \< 2 years
  • Therapy with glucocorticoids or immunosuppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKJ

Jena, Thuringia, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Sophie Tkebuchava, MD

    University Hospital Jena

    PRINCIPAL INVESTIGATOR

  • Torsten Doenst, MD

    University Hospital Jena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Tkebuchava, MD

CONTACT

+4936419322928sophio.tkebuchava@med.uni-jena.de

Torsten Doenst, MD

CONTACT

+4936419322901doenst@med.uni-jena.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 17, 2020

Study Start

March 16, 2021

Primary Completion

March 16, 2022

Study Completion

November 15, 2022

Last Updated

March 23, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)