Observing the effectiveness of pacing therapy for congenital heart disease patients with atrial arrhythmias
ATrial Tachycardia PAcing Therapy in Congenital Heart
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Trial ID | NCT03209583 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 14 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
- Children's Hospital of Orange County (CHOC) — Orange, California, United States (Recruiting)
- Memorial Healthcare System — Hollywood, Florida, United States (Not_yet_recruiting)
- Indiana University Health — Indianapolis, Indiana, United States (Not_yet_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)
- 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)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- 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)
Study contacts
- Study coordinator: Ian Law, MD
- Email: ian-law@uiowa.edu
- Phone: 319-356-7303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.