RecruitingNCT05236153

Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot

Boston Children's HospitalOne US siteView on ClinicalTrials.gov

AI Description

Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability to reduce the risk of VT and sudden cardiac death remains unknown. Thus, in a cohort of participants with rTOF who are presenting for TPVR the investigators intend to: (1) quantify and localize right ventricular (RV) isthmuses with abnormal voltage and/or conduction velocity; (2) identify which RV isthmuses are at risk of being "jailed" by TPV prostheses; and (3) explore the feasibility of omnipolar technology to characterize wavefront directionality and differentiate slow conduction from conduction block.

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Who can join
child, adult, older adult
Participants
60
Expected completion
2024-01-01
Funded by
other

Conditions studied

Sudden Cardiac Death, Tetralogy of Fallot, Ventricular Tachycardia

What is being tested

  • DIAGNOSTIC_TEST: Electroanatomic substrate mapping

What it measures

  • Future arrhythmic event (composite), Documented sustained VT, inducible sustained VT/VF at a future EP study, appropriate ICD therapy for VT/VF, sudden cardiac arrest, 10 years
  • Jailed anatomical isthmus area, Percent jailing of each anatomical RV isthmus (jailed area / isthmus area x100), Immediately after the procedure.

Working with

Abbott

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2023-02-08

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