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ATrial Tachycardia PAcing Therapy in Congenital Heart
NCT03209583 · View on ClinicalTrials.gov ↗
Study 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 medic
Conditions Studied
Interventions
- DEVICE Medtronic
Study Locations (15)
California
- University of California, Los Angeles — Los Angeles
- Children's Hospital of Orange County (CHOC) — Orange
Michigan
- University of Michigan — Ann Arbor
- Children's Hospital of Michigan — Detroit
Florida
- Memorial Healthcare System — Hollywood
Indiana
- Indiana University Health — Indianapolis
Iowa
- University of Iowa Children's Hospital — Iowa City
Kentucky
- Norton Healthcare — Louisville
Minnesota
- Mayo Clinic — Rochester
Ohio
- Rainbow Babies and Children's Hospital — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2027-09-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03209583
The ClinicalTrials.gov registry entry for NCT03209583 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ian Law, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention — of which Medtronic is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03209583 reports 15 study locations spanning 13 distinct geographic areas — top geographies include California, Michigan, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03209583 about?
NCT03209583 is a clinical study titled "ATrial Tachycardia PAcing Therapy in Congenital Heart". 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. ...
What is the current status of trial NCT03209583?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2018-09-01. Estimated completion is 2027-09-01.
What conditions does trial NCT03209583 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Atrial Arrhythmia, Atrial Tachycardia, Pacemaker Re-Entrant Tachycardia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03209583?
The interventions under investigation include: Medtronic (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03209583?
This trial is sponsored by Ian Law, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03209583 being conducted?
This trial has 15 study locations across California, Florida, Indiana, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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