ATrial Tachycardia PAcing Therapy in Congenital Heart

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• must have structural CHD, an atrial arrhythmia and an ATD implanted. ATP must be turned on.

Locations
United States
California
University of California, Los Angeles
NOT_YET_RECRUITING
Los Angeles
Children's Hospital of Orange County (CHOC)
RECRUITING
Orange
Florida
Memorial Healthcare System
NOT_YET_RECRUITING
Hollywood
Iowa
University of Iowa Children's Hospital
RECRUITING
Iowa City
Indiana
Indiana University Health
NOT_YET_RECRUITING
Indianapolis
Kentucky
Norton Healthcare
RECRUITING
Louisville
Michigan
University of Michigan
RECRUITING
Ann Arbor
Children's Hospital of Michigan
RECRUITING
Detroit
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Ohio
Rainbow Babies and Children's Hospital
NOT_YET_RECRUITING
Cleveland
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin, Madison
RECRUITING
Madison
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Haven D Eliot, MD
haven-elliot@uiowa.edu
3193563537
Backup
Ian Law
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 300
Treatments
Congenital Heart Disease
subjects have CHD and arrhythmias being treated with an implanted pacing device.
Sponsors
Collaborators: Mayo Clinic, Vanderbilt University Medical Center, University of Michigan, University of Wisconsin, Madison, Rainbow Babies and Children's Hospital, Children's Hospital of Orange County, Children's Hospital of Michigan, Memorial Healthcare System, Indiana University Health, Norton Healthcare, University of Utah, University of California, Los Angeles, The Hospital for Sick Children
Leads: Ian Law

This content was sourced from clinicaltrials.gov

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