ATrial Tachycardia PAcing Therapy in Congenital Heart (AT-PATCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Atrial Tachycardia; Atrial Arrhythmia; Pacemaker Re-Entrant Tachycardia
• Intervention / Treatment: Device: Medtronic

Detailed Description

University of Iowa is moving to begin the multi-institutional portion of this study by asking for centers to assist with enrollment so that the investigators can meet our enrollment goal. The investigators wish to recruit a minimum of 250 subjects and will collect data for up to 300 subjects. The research team will move to a retrospective and prospective enrollment looking at how well ATP works in ATD therapy devices for patients who have CHD. No interventions will take place as this is a chart review and observational study.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jennifer Maldonado, BS, RTR; Phone Number: 3193564964; Email: jennifer-maldonado@uiowa.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • University of California, Los Angeles
    • Orange, California, United States, 92868
      • Recruiting
      • Children's Hospital of Orange County (CHOC)
      • Contact: Anjan Batra
      • Contact: Brian Lee
  • Florida
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Memorial Healthcare System
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University Health
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Children's Hospital
      • Contact: Emily Riley, BS; Phone Number: 319-356-4964; Email: emily-riley@uiowa.edu
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Healthcare
      • Contact: Chris Johnsrude
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Children's Hospital of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Not yet recruiting
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Rainbow Babies and Children's Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Tina Pham, MD; Phone Number: 713-798-4951; Email: TamDan.Pham@bcm.edu
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Mary Niu
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin, Madison
      • Contact: Nicholas VonBergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Congenital Heart Disease; subjects have CHD and arrhythmias being treated with an implanted pacing device.	Device: Medtronic; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiarrhythmic medication burden	IART is often treated with medication. The dose (mg/kg) for each medication needed to control arrhythmias before and after placement of and ATD will be reviewed.	5 years at minimum
Comparison of ATP protocols of RAMP vs. BURST +	Once the ATD device is implanted there are two types of treatments the ATD is capable of implementing. The investigators will determine the % success rate for both of these treatment modalities for purposes of comparison.	5 years at minimum.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiovascular Abnormalities; Heart Diseases; Tachycardia; Heart Defects, Congenital
• Other Study ID Numbers: 201605847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators are not sharing data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No