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/29246827/Actively Recruiting
Led by Ian Law · Updated on 2026-03-13
300
Participants Needed
15
Research Sites
52 weeks
Total Duration
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
ATrial Tachycardia PAcing Therapy in Congenital Heart
I
Ian Law, MD
M
Mackenzie K Clinical Trials Research Specialist
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Ian Law
Lead Sponsor
Memorial Healthcare System
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or chart review)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Collin C Kramer, Jennifer R Maldonado, Mark D Olson...
https://pubmed.ncbi.nlm.nih.gov/29246827/Collin C Kramer, Jennifer R Maldonado, Mark D Olson...
https://pubmed.ncbi.nlm.nih.gov/32477803/Ian Law
Lead Sponsor
Memorial Healthcare System
Collaborating Sponsor