Safety and efficacy of atrial antitachycardia pacing in congenital heart disease.
Collin C Kramer, Jennifer R Maldonado, Mark D Olson...
https://pubmed.ncbi.nlm.nih.gov/29246827Actively Recruiting
All Genders
ID03209583
Atrial Tachycardia Pacing Therapy in Congenital Heart Disease Observational Study
Led by Ian Law · Updated on 2026-03-13
300
Participants Needed
15
Research Sites
52 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 about 1% of newborns in the US, with many needing open heart surgery in their first year. As patients with CHD live longer, atrial arrhythmias like sinus node dysfunction and intra-atrial re-entrant tachycardia (IART) are common complications. This research aims to evaluate how effective atrial anti-tachycardia pacing (ATP) therapy is for treating IART in different groups of CHD patients, including comparisons between adults and children. The study uses data from past and ongoing patient records to better understand ATP outcomes in this population. Participants have implanted pacing devices that deliver ATP therapy to manage their arrhythmias. The study collects data both retrospectively and prospectively from electronic medical records and pacemaker device checks. Patients are enrolled when their ATP device is implanted or activated, and data includes at least five years of clinical history before and after device use when possible. No new treatments are given since this is an observational study focusing on how well ATP works and any adjustments made to device programming. During the study, participants will have clinical evaluations and follow-up visits every 3 to 6 months. Researchers will assess arrhythmia burden, medication use, and device settings to measure changes before and after ATP therapy. The main outcome is the change in IART burden over at least five years. The study also looks at medication needs and compares different ATP programming methods. Safety and long-term effects are monitored through ongoing clinical data collection until the study ends in 2027.
CONDITIONS
Brief Title
ATrial Tachycardia PAcing Therapy in Congenital Heart
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Must have structural congenital heart disease (CHD), an atrial arrhythmia, and an implanted anti-tachycardia device (ATD) with atrial anti-tachycardia pacing (ATP) turned on.
You will not qualify if you...
- Presence of other arrhythmia conditions such as Long QT syndrome, hypertrophic cardiomyopathy, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular cardiomyopathy.
- 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or chart review)
Long-term Monitoring
Duration - At least 5 years
Participants who have an implanted anti-tachycardia device with atrial pacing are observed over time to assess device performance and arrhythmia burden.
Periodic data collection through chart review
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
M
Mackenzie K Clinical Trials Research Specialist
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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Published Research Related To This Trial
Atrial Antitachycardia Pacing in Complex Congenital Heart Disease: A Case Series.
Collin C Kramer, Jennifer R Maldonado, Mark D Olson...
https://pubmed.ncbi.nlm.nih.gov/32477803