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Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment

NCT05916976 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-06-23

No results posted yet for this study

Summary

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.

Conditions

  • Tetralogy of Fallot
  • Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

cardiac MRI

Multiparametric MRI of the heart

Sponsors & Collaborators

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Joachim Lotz, MD · Institute of Diagnostic and Interventional Radiology, UMG Göttingen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Germany

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 NCT05916976 on ClinicalTrials.gov