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Diagnostic Test
Electroanatomic Mapping for Tetralogy of Fallot
N/A
Recruiting
Led By Edward T O'Leary, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is looking at individuals with repaired Tetralogy of Fallot who are at risk for sudden cardiac death from ventricular tachycardia. The goal is to identify which individuals are at risk and to explore the feasibility of a new technology to help distinguish between slow conduction and conduction block.
Who is the study for?
This trial is for individuals who have had surgery to correct Tetralogy of Fallot or double outlet right ventricle and now need a procedure called TPVR because they're at risk for very fast heartbeats or sudden cardiac death. Participants must weigh at least 25 kg.Check my eligibility
What is being tested?
The study is looking into how the placement of a new valve in the heart (TPVR) might affect areas with abnormal electrical activity that could lead to dangerous heart rhythms, using advanced mapping techniques.See study design
What are the potential side effects?
While specific side effects are not listed, procedures involving the heart like TPVR can generally include risks such as bleeding, infection, arrhythmias, and damage to surrounding structures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Future arrhythmic event (composite)
Jailed anatomical isthmus area
Secondary outcome measures
Number, location, and dimensions of electroanatomically abnormal isthmuses.
Number, location, and dimensions of electroanatomically normal isthmuses.
Presence of any jailed anatomical isthmus
Trial Design
1Treatment groups
Experimental Treatment
Group I: RV mappingExperimental Treatment1 Intervention
Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR.
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
769 Previous Clinical Trials
5,580,469 Total Patients Enrolled
1 Trials studying Tetralogy of Fallot
68 Patients Enrolled for Tetralogy of Fallot
AbbottIndustry Sponsor
752 Previous Clinical Trials
478,305 Total Patients Enrolled
Edward T O'Leary, MDPrincipal InvestigatorBoston Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with tetralogy of Fallot (TOF) or double outlet right ventricle (DORV).You have been recommended to get a transcatheter pulmonary valve replacement for your heart as part of your regular medical care.
Research Study Groups:
This trial has the following groups:- Group 1: RV mapping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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