Recruiting

Atrial Anti-Tachycardia Pacing

Sponsor:

Ian Law

Code:

NCT03209583

Conditions

Atrial Arrhythmia

Atrial Tachycardia

Congenital Heart Disease

Pacemaker Re-Entrant Tachycardia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Medtronic

Study Details

Brief summary:

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

Atrial Arrhythmia

Atrial Tachycardia

Congenital Heart Disease

Pacemaker Re-Entrant Tachycardia

Study ID

NCT03209583

Start date

Sep 1, 2018

Status verified date

Jan, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Congenital Heart Disease

subjects have CHD and arrhythmias being treated with an implanted pacing device.

Interventions

Medtronic

Pacing is done by the implanted device after seeing how the electrical system is functioning giving energy when needed to maintain a stable state or rhythm

Primary outcome measure

  • To measure any change in IART burden before and after ATD implantation. [ Time Frame: 5 years at minimum ]

Central Contacts and Locations

Central contacts

Mackenzie K Clinical Trials Research Specialist

(319) 335-2643Ped-Card-Research@uiowa.edu

Locations

Children's Hospital of Orange County (CHOC)

Recruiting

Orange, California, United States, 92868

University of Iowa Children's Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40202

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

University of Wisconsin, Madison

Recruiting

Madison, Wisconsin, United States, 53792

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

Ian Law

Last update posted

Mar 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ian Law on 2026-03-13.