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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05236153
Status
Recruiting
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Conditions

  • Sudden Cardiac Death
  • Tetralogy of Fallot
  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 4, 2022
Status verified
Feb 2023
Primary completion
Nov 3, 2023
Completion
Jan 1, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: RV mapping
    Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR.

Primary Outcome Measure

Jailed anatomical isthmus area [ Time Frame: Immediately after the procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Edward T O'Leary, MD
[email protected]
617-355-7833

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By research site
Boston Children's Hospital· Boston, MA

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