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

NCT05236153 | Unknown DMC FDA Device

• 1 other identifier: IRB-P00038878
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Presence of any jailed anatomical isthmus

  Immediately after the procedure.

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

  Immediately after the procedure.

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

  Immediately after the procedure.

Study Arms (1)

RV mapping

OTHER

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

Diagnostic Test: Electroanatomic substrate mapping

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.

RV mapping

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Abbott: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Tetralogy of Fallot; Tachycardia, Ventricular; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Edward T O'Leary, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward T O'Leary, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 11, 2022
• Study Start: November 4, 2022
• Primary Completion: November 3, 2023
• Study Completion: January 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)