Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05236153

Conditions

Tetralogy of Fallot

Ventricular Tachycardia

Sudden Cardiac Death

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Electroanatomic substrate mapping

Study Details

Brief summary:

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.

Conditions

Tetralogy of Fallot

Ventricular Tachycardia

Sudden Cardiac Death

Study ID

NCT05236153

Start date

Nov 4, 2022

Status verified date

Feb, 2023

Completion date

Jan 1, 2024

Anticipated

Primary completion date

Nov 3, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: RV mapping

Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR.

Interventions

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.

Primary outcome measure

  • Jailed anatomical isthmus area [ Time Frame: Immediately after the procedure. ]
  • Future arrhythmic event (composite) [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Edward T O'Leary, MD

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

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Edward T O'Leary, MD

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

More Information

Sponsor

Boston Children's Hospital

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2023-02-08.