ATrial Tachycardia PAcing Therapy in Congenital Heart

Congenital Heart Disease Clinical Trial

— AT-PATCH  

Official title:

ATrial Tachycardia PAcing Therapy in Congenital Heart

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209583
• Other study ID #: 201605847
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: Jennifer Maldonado, BS, RTR
• Phone: 3193564964
• Email: jennifer-maldonado[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Tachycardia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pacemaker Re-Entrant Tachycardia
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Memorial Healthcare System	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Iowa Children's Hospital	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Children's Hospital of Orange County (CHOC)	Orange	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (14)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.