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NCT Number: NCT05236153

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.

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Key information

Conditions

Tetralogy of Fallot Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Edward T O'Leary, MD

CONTACT

[email protected]

617-355-7833

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroanatomic substrate mapping

Diagnostic Test

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.

Primary outcomes

  1. Jailed anatomical isthmus area

    Time frame: Immediately after the procedure.

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

  2. Future arrhythmic event (composite)

    Time frame: 10 years

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

Secondary outcomes

  1. Presence of any jailed anatomical isthmus

    Time frame: Immediately after the procedure.

    >50% of an anatomical isthmus covered by the TPV prosthesis

  2. Number, location, and dimensions of electroanatomically normal isthmuses.

    Time frame: Immediately after the procedure.

    isthmuses with omnipolar voltage >1.5 mV and conduction velocity >0.5 m/sec

  3. Number, location, and dimensions of electroanatomically abnormal isthmuses.

    Time frame: Immediately after the procedure.

    isthmuses with omnipolar voltage <1.5 mV and conduction velocity <0.5 m/sec

Study contacts

Contact information is provided by the study sponsor or research team.

Edward T O'Leary, MD

CONTACT

[email protected]

617-355-7833

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 11, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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