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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

763 Previous Clinical Trials

5,580,569 Total Patients Enrolled

1 Trials studying Tetralogy of Fallot

68 Patients Enrolled for Tetralogy of Fallot

AbbottIndustry Sponsor

751 Previous Clinical Trials

478,115 Total Patients Enrolled

Edward T O'Leary, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Electroanatomic substrate mapping (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05236153 — N/A

Tetralogy of Fallot Research Study Groups: RV mapping

Tetralogy of Fallot Clinical Trial 2023: Electroanatomic substrate mapping Highlights & Side Effects. Trial Name: NCT05236153 — N/A

Electroanatomic substrate mapping (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236153 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for potential participants in this research endeavor?

"According to clinicaltrials.gov, the recruitment phase for this experiment is currently active. It was initially uploaded on September 1st 2022 and last updated on August 5th 2022."

Answered by AI

How many individuals are participating in the trial at its peak capacity?

"Affirmative. Clinicaltrials.gov records show that this medical experiment, which first appeared on September 1st 2022, is currently recruiting patients. There are 60 spots available at a single clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Edward O'Leary 2022. "Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236153.