Observing the effectiveness of pacing therapy for congenital heart disease patients with atrial arrhythmias
Official title: ATrial Tachycardia PAcing Therapy in Congenital Heart
Run by University of Iowa · NCT03209583 · Data updated 2026-11-12
This study is testing how well pacing therapy works for people with congenital heart disease who have heart rhythm problems and already have devices to help manage them.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Status | Recruiting |
| Started | September 1, 2018 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT03209583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with structural congenital heart disease, an atrial arrhythmia, and an implanted atrial tachycardia device with ATP activated.
✕Probably not a fit
Patients with other arrhythmia substrates or those who have undergone transplant, surgical maze, or ablation within the last five years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of atrial tachycardia pacing (ATP) therapy in patients with congenital heart disease (CHD) who have implanted atrial tachycardia devices (ATDs). The research will involve both retrospective and prospective data collection from a minimum of 250 subjects across multiple institutions. The study will focus on how well ATP works in managing atrial arrhythmias, particularly in patients who have undergone surgical interventions for CHD. No active interventions will be performed, as the study will primarily analyze existing patient data.
Why it matters
Potential benefit: If successful, this study could improve the management of atrial arrhythmias in patients with congenital heart disease, potentially reducing morbidity and mortality.
How similar studies have gone: While there have been studies on atrial arrhythmias in congenital heart disease, this specific approach to evaluating ATP therapy in a multi-institutional observational setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * must have structural CHD, an atrial arrhythmia and an ATD implanted. ATP must be turned on. Exclusion Criteria: * Other arrhythmias substrates such as Long QT (LQT), hypertrophic Cardiomyopathy (HCM), Catecholaminergic polymorphic ventricular tachycardia (CPVT), Arrhythmogenic Right Ventricular Cardiomyopathy.(ARVC), Brugada \& patients who undergo transplant, surgical maze, or ablation within 5 years of ATD implantation.
Where it's running
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Children's Hospital of Orange County (CHOC)
Orange, California, United States Recruiting -
University of Iowa Children's Hospital
Iowa City, Iowa, United States Recruiting -
Norton Healthcare
Louisville, Kentucky, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Children's Hospital of Michigan
Detroit, Michigan, United States Recruiting -
Baylor College of Medicine
Houston, Texas, United States Recruiting
Show 9 more locations
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University of Utah
Salt Lake City, Utah, United States Recruiting -
University of Wisconsin, Madison
Madison, Wisconsin, United States Recruiting -
The Hospital for Sick Children
Toronto, Ontario, Canada Recruiting -
University of California, Los Angeles
Los Angeles, California, United States Not yet recruiting -
Memorial Healthcare System
Hollywood, Florida, United States Not yet recruiting -
Indiana University Health
Indianapolis, Indiana, United States Not yet recruiting -
Mayo Clinic
Rochester, Minnesota, United States Not yet recruiting -
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States Not yet recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Not yet recruiting
Study contacts
- Study coordinator: Ian Law, MD
- Email: ian-law@uiowa.edu
- Phone: 319-356-7303
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.