Clinical trial Recruiting at 9 sites Observational

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.

More Congenital Heart Disease trials

Quick facts

Study typeObservational
SexAll
Enrollment300 (estimated)
SponsorUniversity of Iowa
Academic / other
Locations15 sites (Los Angeles, California and 14 other locations)
StatusRecruiting
StartedSeptember 1, 2018
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2027
Registry record updatedMarch 13, 2026
Trial IDNCT03209583 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.