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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia; Tetralogy of Fallot; Sudden Cardiac Death
• Intervention / Treatment: Diagnostic test: Electroanatomic substrate mapping

Detailed Description

Participants will receive general endotracheal anesthesia or conscious sedation provided by cardiac anesthesiology and usual vascular access as per routine clinical care for TPVR. The TPVR procedure will be performed per routine care independent of study participation or study findings.

Participants who elect to participate in this research study will undergo RV activation and voltage mapping using a diagnostic electrophysiology mapping catheter. Prior to the delivery of the valve prosthesis, a 3-dimensional electroanatomic map (EAM) of the RV with simultaneous omnipolar voltage and activation data in sinus rhythm will be created using a high-density multielectrode mapping catheter (8 Fr Advisor HD Grid, Abbott Cardiovascular) and an EAM system (Ensite X, Abbott Cardiovascular). Pre-procedural CCT or CMR imaging will be overlayed on the EAM using the tricuspid valve annulus, pulmonary valve annulus, and proximal coronary sinus as fiducial markers for registration. The plane of the pulmonary valve annulus and/or the existing pulmonary valve prosthesis will be annotated on the EAM, referencing the merged CCT/CMR and fluoroscopic images. Ventricular pacing at physiologic rates (60-120 bpm) may be performed to assist in differentiating slow conduction from conduction block and confirming areas of scar. No programmed ventricular stimulation pacing with the intention to induce ventricular arrhythmias will be performed. No catheter ablation will be performed.

Following the completion of the study protocol, participants will be followed prospectively for 10 years to evaluate for the development of the following outcomes: documented sustained clinical VT, inducible sustained VT or ventricular fibrillation during intracardiac electrophysiology study, placement of a primary or secondary prevention implantable cardioverter defibrillator (ICD), appropriate ICD shock for VT/VF, and/or sudden cardiac arrest/death. Participant medical records will be reviewed annually for the development of these outcomes. Informed research consent for future medical record review and research team contact with the participant or primary cardiologist will be obtained.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward T O'Leary, MD; Phone Number: 617-355-7833; Email: edward.oleary@cardio.chboston.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Edward T O'Leary, MD; Phone Number: 617-355-7833; Email: edward.oleary@cardio.chboston.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: RV mapping; Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR.	Diagnostic test: Electroanatomic substrate mapping; Participants will undergo a sinus rhythm RV substrate map using the HD Grid catheter (Abbott) and the Ensite X electroanatomic mapping system (Abbott) prior to TPVR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jailed anatomical isthmus area	Percent jailing of each anatomical RV isthmus (jailed area / isthmus area x100)	Immediately after the procedure.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of any jailed anatomical isthmus	>50% of an anatomical isthmus covered by the TPV prosthesis	Immediately after the procedure.
Number, location, and dimensions of electroanatomically normal isthmuses.	isthmuses with omnipolar voltage >1.5 mV and conduction velocity >0.5 m/sec	Immediately after the procedure.
Number, location, and dimensions of electroanatomically abnormal isthmuses.	isthmuses with omnipolar voltage <1.5 mV and conduction velocity <0.5 m/sec	Immediately after the procedure.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Edward T O'Leary, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2022
• Primary Completion (ANTICIPATED): November 3, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (ACTUAL): February 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Arrest; Death; Tachycardia; Tachycardia, Ventricular; Tetralogy of Fallot; Death, Sudden, Cardiac
• Other Study ID Numbers: IRB-P00038878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No