Atrial Tachycardia Pacing for Congenital Heart Disease
(AT-PATCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a specific pacemaker treatment for individuals with congenital heart disease (CHD) who experience atrial arrhythmias, or irregular heartbeats. The focus is on atrial anti-tachycardia pacing (ATP) to determine if it manages these irregular heartbeats more effectively than current methods. Participants must have CHD, experience atrial arrhythmias, and possess an implanted pacemaker that uses ATP. The goal is to assess whether this therapy can improve symptoms and reduce the need for other treatments, such as medications or procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop your current medications. It seems the focus is on monitoring the effectiveness of the anti-tachycardia device, so you may not need to change your medications, but it's best to confirm with the study team.
What prior data suggests that this device is safe for congenital heart disease patients?
Research has shown that Medtronic's implanted heart devices are generally safe for people with heart conditions. One study found that a modified pacemaker worked safely and effectively to maintain stable heart rhythms in children for at least two years. Another study found that a leadless pacemaker from Medtronic was safe and suitable for children. Additionally, a large study showed that the procedure to implant these devices succeeded in about 98% of patients.
Overall, these findings suggest that Medtronic's heart devices are well-tolerated and reliable for managing heart rhythms, even in complex cases like congenital heart disease (CHD). However, as with any medical treatment, individual experiences may vary, and some patients may have different outcomes.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the use of Medtronic's pacing devices for treating arrhythmias in patients with congenital heart disease (CHD). Unlike traditional treatments that might involve medication or surgical interventions, this approach uses an implanted pacing device to help regulate heart rhythms directly. This technique is particularly intriguing because it offers a more targeted, less invasive solution compared to some existing options. By potentially reducing reliance on medication, which can have various side effects, this pacing therapy could improve quality of life for patients with CHD and arrhythmias.
What evidence suggests that atrial anti-tachycardia pacing is effective for congenital heart disease patients with atrial arrhythmias?
Research has shown that Medtronic's devices for atrial anti-tachycardia pacing (ATP) effectively manage irregular heartbeats in patients with congenital heart disease. One study found that the Medtronic AT500 pacemaker successfully detected and managed these irregular heartbeats in such patients. Another report noted that these devices are reliable, provide effective pacing, and have a long battery life. The evidence suggests that ATP devices could be a promising treatment for reducing heartbeat-related issues in this group, though effectiveness may vary among patients.46789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Data Collection
Patients are enrolled at the time of anti-tachycardia device placement or when device therapies are turned on. Baseline data is collected retrospectively and prospectively.
Follow-up
Participants are monitored for arrhythmia burden and effectiveness of ATP therapy. Follow-ups are scheduled every 3-6 months.
Data Analysis
Statistical analyses are conducted to determine the effectiveness of ATP therapy and any significant differences in efficacy between demographics.
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
subjects have CHD and arrhythmias being treated with an implanted pacing device.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ian Law
Lead Sponsor
University of Wisconsin, Madison
Collaborator
The Hospital for Sick Children
Collaborator
Children's Hospital of Orange County
Collaborator
Rainbow Babies and Children's Hospital
Collaborator
Norton Healthcare
Collaborator
Children's Hospital of Michigan
Collaborator
University of Utah
Collaborator
Memorial Healthcare System
Collaborator
University of California, Los Angeles
Collaborator
Citations
Efficacy of atrial antitachycardia pacing using the Medtronic ...
We evaluated the efficacy of atrial arrhythmia detection and antitachycardia pacing (ATP) using the Medtronic AT500 pacemaker in 28 patients with congenital ...
Multicenter Results of a Novel Pediatric Pacemaker in ...
This multicenter report demonstrates that the devices remain stable, with effective pacing, normal electrical parameters, and battery longevity ...
Leadless Pacemakers: Current Achievements and Future ...
The LEADLESS trial had an overall complication-free rate of 94%, and the Leadless II trial showed device-related serious adverse events in 6.7% ...
Efficacy and Safety of an Extravascular Implantable ...
We found that 32 of 46 monomorphic ventricular tachyarrhythmia events (70%) were treated successfully by pacing from the extravascular space ...
Safety, efficacy, and reliability evaluation of a novel small- ...
The implantation procedure was successful in 643 of 657 (97.9%) patients. Patients received a single-chamber ICD (35.9%), dual-chamber ICD (40.7 ...
New Guidelines of Pediatric Cardiac Implantable Electronic ...
These new Guidelines aim to assess all aspects of cardiac implantable electronic devices and improve treatment strategies.
7.
innovationdistrict.childrensnational.org
innovationdistrict.childrensnational.org/novel-pediatric-pacemaker-shows-safety-effectiveness/Novel pediatric pacemaker shows safety, effectiveness
A pacemaker modified to work better for the smallest children is safe and effective to stabilize heart rhythms for at least two years.
Recent Advancements in Cardiac Implantable Devices for ...
A pediatric based study was also released in 2023 showing that leadless pacing (using the Medtronic Micra™ device) was reasonable and safe in a ...
Pacing and Defibrillators in Complex Congenital Heart Disease
In a retrospective study of 287 patients with CHD, Silvetti et al. found a clear survival benefit of transvenous leads (10-year lead survival 71 % versus 95 %, ...
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