FASS-prosp study

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AEPC TEACHING COURSES FOR TRAINEES

FASS-prosp study

AEPC study on Effect of fetal aortic valvuloplasty on outcomes. A prospective observational cohort study with a comparison cohort (FASS-prosp study)

In a proportion of fetuses with aortic valve stenosis the cardiac defect will evolve into hypoplastic left heart syndrome (HLHS) before birth. Fetal aortic valvuloplasty has been suggested as a method to prevent evolution into HLHS but the level of evidence in previous studies is low. To address the shortcomings of previous studies we are undertaking an international prospective observational cohort study with a comparison cohort.

Contact details

If you are interested in joining this study please send an email to Annika Öhman and to Mats Mellander:

  • Annika Öhman (Core lab PI): annika.ohman <at> vgregion.se
  • Mats Mellander (Study PI): mats.mellander <at> vgregion.se

Links to further reading about the study

Overview of the study >

Detailed research program >

Inclusion and exclusion criteria

These are identical in the intervention and non-intervention groups:

LINK: Inclusion criteria >                

LINK: Exclusion criteria > 

Echocardiographic measurements

Echo data are uniformly obtained according to the following instructions:

Manual of fetal echo >

Manual of postnatal echo >

Data collection and online database

Collection of clinical data and echocardiographic measurements will be through electronic Case Report Forms (eCRF) to an online database (MediCase).

 MediCase database – instructions for user >

Quick guide to MediCase >

MediCase eCRF - company and system security >

Annotated eCRF (all variables in MediCase database in detail) >

Instruction videos for the MediCase online database

MediCase I – How to begin – inclusion and baseline fetal echo MediCase

MediCase II – Additional forms

MediCase III – Neonatal forms

MediCase IV – 2- years follow-up

Core laboratory

Echocardiographic exams will be uploaded to a core laboratory FTPS server managed by the University of Gothenburg.

Core lab – instructions for user >

Quick guide to Core lab FTPS server >

Core lab FTPS server security >

How to anonymize an exam in Voluson >       

Instruction video FTPS server

FTPS server – How to upload echoes:

Statistical analysis

Data analysis and statistical analysis plan (SAP) >

Publication of results

Co-authorship will be based on the criteria published by ICMJE.

ICMJE statement on co-authorship >

Steering group

The steering group has at least one member from each country.

 LINK: Steering group members

pdf


1-overview-of-the-study.pdf

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2-short-instruction-for-new-local-investigators.pdf

66.56 kB

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3-fassprosp-research-program-version-2022-02-21.pdf

335.56 kB

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4-consent-form-in-english.pdf

79.59 kB

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5-medicase-ecrf-company-and-system-security.pdf

190.24 kB

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6-core-lab-server-security.pdf

450.55 kB

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7-core-lab-instructions-for-user.pdf

3.95 MB

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8-medicase-instructions-for-user.pdf

2.68 MB

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9-quick-guide-to-core-lab-ftps-server-and-medicase.pdf

339.81 kB

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10-how-to-anonymize-an-exam-in-voluson-us-2.pdf

20.03 MB

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11-manual-of-fetal-echo.pdf

5.02 MB

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12-manual-of-postnatal-echo.pdf

7 MB

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13-fassprosp-annotated-crf-version-18.pdf

2.15 MB

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14-statistical-analysis-plan-sap-final-20210318.pdf

347.56 kB

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