Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Children's Hospital

About this trial

Doctors use patterns on heart rhythm tracings (ECGs) to predict where abnormal heart rhythms originate, but these prediction methods were developed in people with normal heart structure. Patients with repaired Tetralogy of Fallot have hearts that developed differently, and cardiologists do not know if these prediction methods work accurately for them. In this study, the investigators will test whether three commonly used prediction methods work in Tetralogy of Fallot patients by pacing the heart from known locations during an already-scheduled heart procedure and comparing the predicted location to the actual location. Participation adds approximately 15 minutes to the procedure and does not require additional visits. The results will help cardiologists understand whether current methods can be trusted when planning treatments for abnormal heart rhythms in this patient population, or whether new prediction methods need to be developed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients >/= 18 years with repaired tetralogy of Fallot with pulmonary stenosis scheduled for clinically-indicated diagnostic electrophysiology (EP) study.

Disqualifiers

Dextrocardia or mesocardia.

Double outlet right ventricle.

Tetralogy of Fallot with pulmonary atresia.

Contraindication to femoral arterial access.

Trial design

Design model

Single group

Treatments tested in this trial

  • RV and LV pace mapping

    Diagnostic test

    Pace mapping at systematic RV and LV sites according to select published VT/PVC localization schema will be performed in study patients.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pace MappingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Algorithm accuracy (%)

The proportion of correctly identified pace sites among all evaluable pace sites, and analyzed separately for each algorithm according to its intended classification scheme. Concordance at each pace site will be assessed as a binary outcome.

Time frame
From enrollment to completion of the pacing protocol during their EP study.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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