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

Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot: A Prospective Pace Mapping Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07607821
Enrollment
30
Registered
2026-05-26
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot (TOF), Ventricular Tachycardia

Brief summary

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.

Interventions

DIAGNOSTIC_TESTRV and LV pace mapping

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

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Dextrocardia or mesocardia. * Double outlet right ventricle. * Tetralogy of Fallot with pulmonary atresia. * Contraindication to femoral arterial access. * Mechanical aortic prosthesis. * Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Algorithm accuracy (%)From enrollment to completion of the pacing protocol during their EP study.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.

Contacts

CONTACTEdward T O'Leary, MD
edward.oleary@cardio.chboston.org617-355-7833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026