Clinical trial NCT03209583: ATrial Tachycardia PAcing Therapy in Congenital Heart
Official title: ATrial Tachycardia PAcing Therapy in Congenital Heart
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Arrhythmia
Atrial Tachycardia
Congenital Heart Disease
Pacemaker Re-Entrant Tachycardia
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Memorial Healthcare System
name: Children's Hospital of Michigan
name: Indiana University Health
name: Mayo Clinic
name: Rainbow Babies and Children's Hospital
name: The Hospital for Sick Children
name: University of Wisconsin, Madison
name: University of California, Los Angeles
name: University of Utah
name: Norton Healthcare
name: University of Michigan
name: Vanderbilt University Medical Center
name: Children's Hospital of Orange County
First posted: 2017-07-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: To measure any change in IART burden before and after ATD implantation.
timeFrame: 5 years at minimum
Secondary outcomes:
measure: Antiarrhythmic medication burden
timeFrame: 5 years at minimum
measure: Comparison of ATP protocols of RAMP vs. BURST +
timeFrame: 5 years at minimum.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County (CHOC)
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.