Actively Recruiting

All Genders
NCT03209583

ATrial Tachycardia PAcing Therapy in Congenital Heart

Led by Ian Law · Updated on 2026-03-13

300

Participants Needed

15

Research Sites

469 weeks

Total Duration

On this page

Sponsors

I

Ian Law

Lead Sponsor

M

Memorial Healthcare System

Collaborating Sponsor

AI-Summary

What this Trial Is About

Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth. Surgical and medical advances have allowed many patients to live beyond their fourth and fifth decades of life. Unfortunately, cardiac arrhythmias are a relatively common sequela due to cardiac anomalies and surgical scars in addition to residual volume and pressure load on the heart. Atrial arrhythmias, including sinus node dysfunction and intra-atrial re-entrant tachycardia (IART) are among the more common abnormalities found in adults with repaired CHD. The presence of IART significantly increases morbidity and mortality, and anti-arrhythmic medications have been shown to be a sub-optimal treatment strategy with the majority of patients requiring multi-drug therapy. Catheter ablation procedures remain a treatment option, but are less successful for some patient demographics. In the mid-1990's, pacemakers with atrial anti-tachycardia pacing (ATP) capabilities were developed, primarily for the management of atrial flutter and fibrillation in adults with structurally normal hearts. Given the need for pacemakers in the CHD population to manage sinus node dysfunction and atrioventricular node conduction block, the adoption of atrial anti-tachycardia pacemakers began to gain favor. However, there is limited data available comparing the safety and effectiveness of ATP therapy between various demographics of CHD patients. In the current study, the investigators aim to determine if ATP is an effective treatment strategy for IART, specifically within particular sub-populations of CHD patients. Additionally, investigators hope to delineate any significant differences in efficacy of ATP treatment between adult and pediatric congenital heart patients. The research team will accomplish our goals with a retrospective, multi-center study in which data is collected from existing electronic medical records and pacemaker interrogations. Following data collection, the investigators will employ statistical analyses to determine if certain CHD demographics are statistically significant predictors of ATP therapy outcomes. The purpose of this prospective/retrospective study is to determine how effective atrial anti-tachycardia therapies are with the congenital heart patients who are known to have atrial arrhythmias. As this population ages, we know that arrhythmic burden increases and medications are increased or changed for symptomatic improvement. Patients will be enrolled at the time of anti tachycardia device (ATD) placement or when device therapies are turned on. Patients will need a minimum of 5 years of clinical history prior to implantation and after implantation (unless patient is very young). Data will be collected both retrospectively and prospectively. The research team will consent patients at the time of clinical evaluations and scheduled follow-ups (usually 3 - 6 months). If therapy is effective, investigators will determine the specific programming which was successful. If therapy was ineffective, investigators will also determine if a change in programing was made and if this improved ATP efficacy. Investigators will also determine the arrhythmia burden. Cardioversion and medications before and after ATD implantation will be the key determinants of arrhythmia burden in this study.

CONDITIONS

Official Title

ATrial Tachycardia PAcing Therapy in Congenital Heart

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have structural congenital heart disease (CHD)
  • Must have an atrial arrhythmia
  • Must have an anti-tachycardia device (ATD) implanted with atrial anti-tachycardia pacing (ATP) turned on
Not Eligible

You will not qualify if you...

  • Presence of other arrhythmia conditions such as Long QT syndrome, hypertrophic cardiomyopathy, catecholaminergic polymorphic ventricular tachycardia, arrhythmogenic right ventricular cardiomyopathy, or Brugada syndrome
  • Patients who have undergone heart transplant, surgical maze procedure, or ablation within 5 years before ATD implantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Not Yet Recruiting

2

Children's Hospital of Orange County (CHOC)

Orange, California, United States, 92868

Actively Recruiting

3

Memorial Healthcare System

Hollywood, Florida, United States, 33021

Not Yet Recruiting

4

Indiana University Health

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

5

University of Iowa Children's Hospital

Iowa City, Iowa, United States, 52242

Actively Recruiting

6

Norton Healthcare

Louisville, Kentucky, United States, 40202

Actively Recruiting

7

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

8

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

9

Mayo Clinic

Rochester, Minnesota, United States, 55901

Not Yet Recruiting

10

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States, 44106

Not Yet Recruiting

11

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Not Yet Recruiting

12

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

13

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

14

University of Wisconsin, Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

15

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

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Research Team

I

Ian Law, MD

CONTACT

M

Mackenzie K Clinical Trials Research Specialist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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