AzTrials
AzTrials

Atrial ArrhythmiaAT-PATCHNCT03209583

ATrial Tachycardia PAcing Therapy in Congenital Heart

An observational study of Atrial Arrhythmia and Atrial Tachycardia, run by Ian Law at 15 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Medtronic
Type of treatment
Medical device
How many people
300 participants
Where
15 sitesin 2 countries
Study dates
1 Sep 2018to 1 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Mackenzie K Clinical Trials Research Specialist contact

(319) 335-2643

Ped-Card-Research@uiowa.edu

15 sites in 2 countries

United States14 sites, 14 recruiting
  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting
  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

    Not yet recruiting
  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Recruiting
  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Not yet recruiting
  • Baylor College of Medicine

    Houston, Texas, 77030

    Tina Pham, MD, 713-798-4951, TamDan.Pham@bcm.edu

    Recruiting
  • Indiana University Health

    Indianapolis, Indiana, 46202

    Not yet recruiting
  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242

    Emily Riley, BS, 3193564964, emily-riley@uiowa.edu

    Recruiting
  • University of California, Los Angeles

    Los Angeles, California, 90095

    Not yet recruiting
  • Norton Healthcare

    Louisville, Kentucky, 40202

    Chris Johnsrude

    Recruiting
  • University of Wisconsin, Madison

    Madison, Wisconsin, 53792

    Nicholas VonBergen

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Not yet recruiting
  • Children's Hospital of Orange County (CHOC)

    Orange, California, 92868

    Anjan Batra

    Brian Lee

    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55901

    Not yet recruiting
  • University of Utah

    Salt Lake City, Utah, 84132

    Mary Niu

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting
  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Medtronic
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedtronicDevice

    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

Study groups in NCT03209583
Study groupRoleWhat they receive
Congenital Heart Diseasesubjects have CHD and arrhythmias being treated with an implanted pacing device.
Receives: Device: Medtronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years at minimum

Secondary outcomes (2)
  1. 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.

    Measured: 5 years at minimum

  2. 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.

    Measured: 5 years at minimum.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2017
  2. Study start1 Sep 2018
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03209583
Sponsor's protocol ID
201605847
Acronym
AT-PATCH
Status last verified
Jan 2026
First submitted
7 Jun 2017
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Investigators are not sharing data with other researchers

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.

    PubMed 29246827
  • 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.

    PubMed 32477803

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Arrhythmia and Atrial Tachycardia, run by Ian Law at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ian Law, MD (319-356-7303, ian-law@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure any change in IART burden before and after ATD implantation. (time frame: 5 years at minimum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03209583, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in