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NCT03209583 · ClinicalTrials.gov registry record
ATrial Tachycardia PAcing Therapy in Congenital Heart
A clinical trial of Congenital Heart Disease and Atrial Arrhythmia, sponsored by Ian Law.
- Recruiting
- Registry status
- 300
- Enrollment target
- 15
- Study locations
NCT03209583: Recruiting study of Congenital Heart Disease and Atrial Arrhythmia, sponsored by Ian Law.
NCT03209583 is a study of Congenital Heart Disease and Atrial Arrhythmia that is actively recruiting participants, run by Ian Law. The registered enrollment target is 300 participants, below the 469-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (36% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03209583, a study of Congenital Heart Disease and Atrial Arrhythmia, is actively recruiting participants, sponsored by Ian Law.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 15
- Study locations
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
Primary Outcome
The comparison will be how many times a cardioversion was needed and or how many times the device was able to or wasn't able to pace the heart out of the fast rate which could otherwise have been treated with a cardioversion. Data will be collected for a maximum of 5 years prior to implantation of an ATD and compared to a maximum of 5 years post implantation.
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 |
What NCT03209583 shows while recruiting
NCT03209583 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 469-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (36% lower).
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.
NCT03209583 lists 15 locations in 13 states (California, Michigan, Florida).
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.
What interventions are being tested in trial NCT03209583?
The interventions under investigation include: Medtronic (DEVICE).
Who is sponsoring clinical trial NCT03209583?
This trial is sponsored by Ian Law, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03209583's enrollment target sits among peer trials
300 11th of 63 higher than 51 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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