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Recruiting NCT05122962

Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

— Observational Tetralogy of Fallot Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Heart Rhythm Monitoring.
Who it may be relevant to
Registry conditions: Tetralogy of Fallot, Congenital Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)

Interventions

  • Diagnostic test Remote Heart Rhythm Monitoring
    We will be looking to see if remote heart rhythm monitoring for 30 days at baseline, 12, and 24 months, helps for early identification of adverse cardiac events.

Primary outcome measures

  • Right Heart Remodeling [Time frame: 24 Months]
Secondary outcome measures (2)
  • Incident arrhythmias [Time frame: 24 Months]
  • Aerobic Capacity [Time frame: 24 Months]

Eligibility criteria

Inclusion criteria

  • Moderate (or greater) PR based on quantitative Doppler echocardiography.
  • Repaired TOF
  • Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.

Exclusion criteria

  • Pregnant Women
  • Unable to undergo CMRI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05122962 · 21-005062 · R01HL158517

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗