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

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ClinicalTrials.gov Identifier: NCT03209583
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : April 11, 2019
Sponsor:
Collaborators:
Memorial Healthcare System
Children's Hospital of Michigan
Indiana University Health
Mayo Clinic
Rainbow Babies and Children's Hospital
The Hospital for Sick Children
University of Wisconsin, Madison
University of California, Los Angeles
University of Utah
Norton Healthcare
University of Michigan
Vanderbilt University Medical Center
Children’s Hospital of Orange County
Information provided by (Responsible Party):
Ian Law, University of Iowa

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.


Condition or disease Intervention/treatment
Atrial Arrhythmia Atrial Tachycardia Congenital Heart Disease Pacemaker Re-Entrant Tachycardia 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: ATrial Tachycardia PAcing Therapy in Congenital Heart
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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




Primary Outcome Measures :
  1. To measure any change in IART burden before and after ATD implantation. [ Time Frame: 5 years at minimum ]
    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.


Secondary Outcome Measures :
  1. Antiarrhythmic medication burden [ Time Frame: 5 years at minimum ]
    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.

  2. Comparison of ATP protocols of RAMP vs. BURST + [ Time Frame: 5 years at minimum. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209583


Contacts
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Contact: Jennifer Maldonado, BS, RTR 3193564964 jennifer-maldonado@uiowa.edu

Locations
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United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Children's Hospital of Orange County (CHOC) Recruiting
Orange, California, United States, 92868
Contact: Anjan Batra         
Contact: Brian Lee         
United States, Florida
Memorial Healthcare System Not yet recruiting
Hollywood, Florida, United States, 33021
United States, Indiana
Indiana University Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jennifer Maldonado, BS, RTR    319-356-4964    jennifer-maldonado@uiowa.edu   
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Chris Johnsrude         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55901
United States, Ohio
Rainbow Babies and Children's Hospital Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Mary Niu         
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Nicholas VonBergen         
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Ian Law
Memorial Healthcare System
Children's Hospital of Michigan
Indiana University Health
Mayo Clinic
Rainbow Babies and Children's Hospital
The Hospital for Sick Children
University of Wisconsin, Madison
University of California, Los Angeles
University of Utah
Norton Healthcare
University of Michigan
Vanderbilt University Medical Center
Children’s Hospital of Orange County

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Responsible Party: Ian Law, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03209583     History of Changes
Other Study ID Numbers: 201605847
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Investigators are not sharing data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Diseases
Tachycardia
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes