ATrial Tachycardia PAcing Therapy in Congenital Heart

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

Interventions

DEVICE

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

Sponsors & Collaborators

• Memorial Healthcare System

  collaborator OTHER

• Indiana University Health

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Rainbow Babies and Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Norton Healthcare

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• Ian Law

  lead OTHER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2026-09-01

Completion

2027-09-01

FDA Device

Yes

Countries

• United States
• Canada

Study Locations