Electroanatomic Interactions in Repaired Tetralogy of Fallot

This study is for individuals with repaired Tetralogy of Fallot (rTOF), a heart condition, who are scheduled to receive a transcatheter pulmonary valve replacement (TPVR). People with rTOF can be at risk for a fast heart rhythm called ventricular tachycardia (VT) and sudden cardiac death. Researchers want to understand if TPVR can help reduce this risk. They will use a diagnostic test called electroanatomic substrate mapping with an HD Grid catheter and Ensite X system to create a detailed map of the heart's right ventricle before the TPVR procedure. This will help them identify areas that might cause VT and see how the new valve interacts with these areas. The study aims to enroll 60 participants who weigh at least 25 kg.

Study design
This is an interventional study with a planned enrollment of 60 participants. It is not specified if it is randomized or blinded.
What's involved
If you participate, you will undergo a diagnostic electrophysiology mapping procedure to create a 3-dimensional map of your heart's right ventricle before your TPVR. This mapping uses a high-density multielectrode catheter and an electroanatomic mapping system.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track future arrhythmic events for up to 10 years after the procedure.

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NCT05236153

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

Recruiting
NAAll AgesInterventionalDiagnostic
Boston Children's Hospital
~60 participants
Updated 2023-02-08 on ClinicalTrials.gov
What's tested:Electroanatomic substrate mapping

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Jailed anatomical isthmus area
Measured over Immediately after the procedure.
+1 more outcome measured
Tetralogy of Fallot
Ventricular Tachycardia
Sudden Cardiac Death
1 sites across 1 states
Massachusetts1
  • Edward T O'Leary, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV)
Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications
Weight \>=25 kg
  • Jailed anatomical isthmus areaImmediately after the procedure.

    Percent jailing of each anatomical RV isthmus (jailed area / isthmus area x100)

  • Future arrhythmic event (composite)10 years

    Documented sustained VT, inducible sustained VT/VF at a future EP study, appropriate ICD therapy for VT/VF, sudden cardiac arrest