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

NCT07607821 | Not Yet Recruiting DMC

• 1 other identifier: IRB-P00053499
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tetralogy of Fallot (TOF); Ventricular Tachycardia

Outcome Measures

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.

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

Study Arms (1)

Pace Mapping

EXPERIMENTAL

Patients presenting for clinically-indicated EP study will undergo systematic pace mapping from RV and LV sites according to published PVC/VT localization algorithm schema.

Diagnostic Test: RV and LV pace mapping

Interventions

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.

Pace Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Tetralogy of Fallot; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edward T O'Leary, MD

CONTACT

617-355-7833; edward.oleary@cardio.chboston.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share