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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 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.

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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

Conditions Studied

Congenital Heart Disease Atrial Arrhythmia Atrial Tachycardia Pacemaker Re-Entrant Tachycardia

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

FieldValue
Enrollment Target 300 participants
Start Date 2018-09-01
Est. Completion 2027-09-01

Sponsor

Ian Law

1 total trials

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What the Registry Record Tells You About NCT03209583

The ClinicalTrials.gov registry entry for NCT03209583 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 469-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (36% lower). The listed sponsor is Ian Law, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 15 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.