ATrial Tachycardia PAcing Therapy in Congenital Heart

NCT03209583 | Recruiting DMC FDA Device

• 1 other identifier: 201605847
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 15

Brief 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 medical records and pacemaker interrogations. Following data collection, the investigators will employ statistical analyses to determine if certain CHD demographics are statistically significant predictors of ATP therapy outcomes. The purpose of this prospective/retrospective study is to determine how effective atrial anti-tachycardia therapies are with the congenital heart patients who are known to have atrial arrhythmias. As this population ages, we know that arrhythmic burden increases and medications are increased or changed for symptomatic improvement. Patients will be enrolled at the time of anti tachycardia device (ATD) placement or when device therapies are turned on. Patients will need a minimum of 5 years of clinical history prior to implantation and after implantation (unless patient is very young). Data will be collected both retrospectively and prospectively. The research team will consent patients at the time of clinical evaluations and scheduled follow-ups (usually 3 - 6 months). If therapy is effective, investigators will determine the specific programming which was successful. If therapy was ineffective, investigators will also determine if a change in programing was made and if this improved ATP efficacy. Investigators will also determine the arrhythmia burden. Cardioversion and medications before and after ATD implantation will be the key determinants of arrhythmia burden in this study.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To measure any change in IART burden before and after ATD implantation.

  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.

  5 years at minimum

Secondary Outcomes (2)

• Antiarrhythmic medication burden

  5 years at minimum

• Comparison of ATP protocols of RAMP vs. BURST +

  5 years at minimum.

Study Arms (1)

Congenital Heart Disease

subjects have CHD and arrhythmias being treated with an implanted pacing device.

Device: Medtronic

Interventions

Medtronic DEVICE

Pacing is done by the implanted device after seeing how the electrical system is functioning giving energy when needed to maintain a stable state or rhythm

Congenital Heart Disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and adults with structural congenital heart disease, with documented atrial arrhythmia (IART, CHB, SND), and with an ATD which has therapies enabled. Patients will all be seen by providers at the University of Iowa Children's Hospital.

You may qualify if:

• must have structural CHD, an atrial arrhythmia and an ATD implanted. ATP must be turned on.

You may not qualify if:

• Other arrhythmias substrates such as Long QT (LQT), hypertrophic Cardiomyopathy (HCM), Catecholaminergic polymorphic ventricular tachycardia (CPVT), Arrhythmogenic Right Ventricular Cardiomyopathy.(ARVC), Brugada \& patients who undergo transplant, surgical maze, or ablation within 5 years of ATD implantation.

Sponsors & Collaborators

• Ian Law: lead
• Memorial Healthcare System: collaborator
• Indiana University Health: collaborator
• Mayo Clinic: collaborator
• Rainbow Babies and Children's Hospital: collaborator
• The Hospital for Sick Children: collaborator
• University of Wisconsin, Madison: collaborator
• University of California, Los Angeles: collaborator
• University of Utah: collaborator
• Norton Healthcare: collaborator
• University of Michigan: collaborator
• Vanderbilt University Medical Center: collaborator
• Children's Hospital of Orange County: collaborator

Study Sites (15)

University of California, Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Children's Hospital of Orange County (CHOC)

Orange, California, 92868, United States

RECRUITING

Memorial Healthcare System

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Healthcare

Louisville, Kentucky, 40202, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55901, United States

NOT YET RECRUITING

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (2)

• Kramer CC, Maldonado JR, Olson MD, Gingerich JC, Ochoa LA, Law IH. Safety and efficacy of atrial antitachycardia pacing in congenital heart disease. Heart Rhythm. 2018 Apr;15(4):543-547. doi: 10.1016/j.hrthm.2017.12.016. Epub 2017 Dec 12.

  PMID: 29246827 BACKGROUND

• Kramer CC, Maldonado JR, Olson MD, Gingerich JC, Ochoa LA, Law IH. Atrial Antitachycardia Pacing in Complex Congenital Heart Disease: A Case Series. J Innov Card Rhythm Manag. 2018 Mar 15;9(3):3079-3083. doi: 10.19102/icrm.2018.090304. eCollection 2018 Mar.

  PMID: 32477803 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ian Law, MD

CONTACT

319-356-7303; ian-law@uiowa.edu

Mackenzie K Clinical Trials Research Specialist

CONTACT

(319) 335-2643; Ped-Card-Research@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: July 6, 2017
• Study Start: September 1, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (14)