Tetralogy of Fallot Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Edward T O'Leary, MD
edward.oleary@cardio.chboston.org
617-355-7833
Time Frame
Start Date: 2022-11-04
Estimated Completion Date: 2024-01-01
Participants
Target number of participants: 60
Treatments
Other: RV mapping
Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR.
Sponsors
Leads: Boston Children's Hospital
Collaborators: Abbott

This content was sourced from clinicaltrials.gov