Actively Recruiting
Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
Led by Boston Children's Hospital · Updated on 2023-02-08
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying individuals with repaired Tetralogy of Fallot (rTOF) who remain at risk for sudden cardiac death due to ventricular tachycardia (VT). This study aims to understand how transcatheter pulmonary valve replacement (TPVR) affects the heart's electrical pathways, specifically the right ventricular (RV) isthmuses, and to explore new technology for mapping heart electrical activity. The goal is to better identify and characterize areas at risk during TPVR procedures. Participants will undergo TPVR as part of their standard care. Before the valve is placed, a detailed 3-dimensional electroanatomic map of the RV will be created using a specialized high-density catheter and mapping system. This mapping includes overlaying prior imaging and assessing heart electrical activity during normal rhythm and paced heartbeats. No attempts will be made to induce arrhythmias or perform ablation during the procedure. After the procedure, participants will be followed for 10 years to track heart rhythm events such as ventricular tachycardia, ventricular fibrillation, ICD placement or shocks, and sudden cardiac arrest or death. Annual medical record reviews will support this long-term monitoring. The study measures the area of RV isthmuses affected by the valve immediately after TPVR and monitors arrhythmic events over time.
CONDITIONS
Brief Title
Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV)
- Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications
- Weight \u226525 kg
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of TPVR procedure
Participants undergo a sinus rhythm right ventricular electroanatomic substrate map prior to transcatheter pulmonary valve replacement (TPVR). This involves the use of specialized catheters and mapping systems during the procedure performed under anesthesia or sedation as part of routine care.
1 procedure visit (in-person)
Duration - 10 years
Participants are followed prospectively for 10 years after the procedure to monitor for arrhythmic events and other cardiac outcomes through annual medical record reviews and contact with participants or their cardiologists.
Annual follow-up visits or contacts
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Edward T O'Leary, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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