Wolff-Parkinson-White Syndrome

Researchers are investigating the role of focal electrical activations in maintaining persistent atrial fibrillation (AF). The study evaluates a new mapping technique called RETRO-Mapping, designed to detect these focal activations during AF. This approach aims to better understand the mechanisms behind persistent AF and whether targeting these focal drivers can improve treatment outcomes compared to standard care. All participants will undergo a standard pulmonary vein isolation (PVI) procedure using advanced 3D electroanatomic mapping systems. After PVI, patients are randomly assigned to either a control group, which receives RETRO-Mapping without additional ablation, or an intervention group, where RETRO-Mapping is used to identify and ablate focal activation sites. The intervention includes mapping 30-second segments of the atria, ablating identified focal activations, and assessing changes in AF cycle length to evaluate treatment effects. Participants will be monitored through detailed intra-procedural measurements, including AF cycle length in the coronary sinus and left atrial appendage. The main outcome is the change in AF cycle length during the procedure, and a secondary outcome is freedom from AF one year after treatment. The study involves follow-up assessments and safety monitoring, with a total participation duration extending to at least one year to track long-term effects and recurrence.

Researchers are collecting data through a registry to study the outcomes of implantable cardioverter-defibrillators (ICDs) placed in ambulatory surgical centers for patients with arrhythmia. The main goals are to determine how often serious complications or adverse events occur with both initial and replacement ICD implants and to evaluate the time and cost efficiency for doctors and patients. This registry gathers information at several points: during screening, at the time of implant, and two weeks afterward during a wound check. The study focuses on patients receiving ICD devices in outpatient ambulatory surgical centers, without comparison groups or experimental treatments. Participants will have their implantation success assessed at a two-week follow-up. Data collection includes monitoring for complications and efficiency outcomes. The registry runs from August 2017 until August 2028, and participants will undergo routine clinical evaluations associated with their ICD implantation and follow-up care.

Cryptogenic stroke (CS) causes about 30% of stroke unit admissions and often has an unknown cause. Silent paroxysmal atrial fibrillation (PAF) is believed to underlie many CS cases. This study evaluates the usefulness of implantable cardiac monitors (ICM) for early detection of silent PAF in patients with CS. The study also explores clinical and ultrasound predictors, such as atrial contraction strain (ACS), to identify patients at higher risk who may need closer monitoring. Patients admitted with CS are randomized within 48 hours of admission to either standard care or early ICM implantation before discharge. The ICM devices are implanted subcutaneously in the chest and programmed to detect atrial fibrillation episodes lasting 30 seconds or more. The study also uses cardiac ultrasound to assess atrial features like left atrial volume and strain to classify patients as having atrial cardiomyopathy or not. Standard care includes continuous ECG monitoring for at least 48 hours and follow-up ECGs and Holter monitoring. Participants undergo neurological exams, ECGs, brain imaging, and blood tests during admission and are followed up in outpatient clinics at 3, 6, 12 months, and every 6 months thereafter up to 2 years. Researchers will monitor for atrial fibrillation detection confirmed by ECG or device recordings, assess ultrasound predictors of PAF, and track stroke recurrence. All ICM recordings are reviewed by specialists, and oral anticoagulation is started if atrial fibrillation is detected.

Researchers are evaluating the safety and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device, also known as the Aveir20 AR LP system. This coverage with evidence development (CED) study focuses on Medicare patients implanted with this device or a similar single-chamber atrial transvenous pacemaker from any manufacturer. The study uses real-world evidence by merging multiple data sources from Abbott and the Center for Medicare Services to better understand device-related complications and survival rates. This observational study collects data without requiring any new device intervention. It includes two groups: patients implanted with the Aveir AR Leadless Pacemaker and those with a single-chamber atrial transvenous pacemaker, serving as a comparison group. Both groups' data come from real-world healthcare records, allowing researchers to assess outcomes over time without affecting patient treatment. Participants' health data will be monitored for complications within 30 days and up to two years, including acute and chronic device-related issues and any need for device re-intervention. The study uses Medicare claims data and does not require individual patient consent due to an approved waiver. Outcomes such as survival rates and complication frequencies are tracked to understand device performance in real-world use, with the study planned to continue through January 2031.

This research aims to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device, also called the Aveir DR LP system, among Medicare patients. It is a coverage with evidence development (CED) study using real-world evidence methods to merge data from Abbott and the Center for Medicare Services. The study includes patients who have received either the Aveir DR LP system or a dual-chamber transvenous pacemaker from any manufacturer. The study involves collecting real-world data from two groups: patients implanted with the Aveir DR Leadless Pacemaker System and patients with a dual-chamber transvenous pacemaker system as a comparison group. No new device interventions are required during the study. Data collection relies on existing claims and health records, and individual patient consent is waived under central institutional review board approval. Participants will be observed through merged real-world datasets without additional visits or procedures. Researchers will monitor device-related complication rates at 30 days and 6 months, device-related re-intervention rates at 2 years, and overall survival at 2 years. The study includes Medicare beneficiaries implanted with the devices on or after the study start date, and participation involves ongoing data review to assess safety and health outcomes over time.

This research aims to evaluate the long-term safety of the Aveir dual-chamber leadless pacemaker in patients with cardiac pacemakers, arrhythmia, or bradycardia. It is an observational post-approval study designed to provide safety data by using real-world evidence methods and merging multiple data sets from Abbott and the Center for Medicare Services. This study fulfills FDA conditions of approval for the Aveir DR device. The study uses data from patients already implanted with the Aveir DR Leadless Pacemaker System, without performing any new device interventions. Data collection is based on real-world evidence and involves no randomization or treatment assignment. The study utilizes a central institutional review board approved waiver of informed consent, so individual hospitals do not need to obtain patient consent or conduct local IRB submissions. The focus is on monitoring safety outcomes over time. Participants are tracked through linked Medicare data to assess complications related to the device at both 30 days and over 5 years. The study measures the number of subjects free from acute and chronic device-related complications and records end-of-device service events. The total duration of follow-up extends up to five years, using real-world data to monitor long-term device safety and performance.

Researchers are evaluating the complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP). This observational coverage with evidence development study compares the safety and health results of the Aveir VR LP to those of patients implanted with single-chamber transvenous pacemakers from any manufacturer. The study uses a large patient population by merging real-world data from Abbott and the Center for Medicare Services. The study includes Medicare patients implanted with either the Aveir VR Leadless Pacemaker System or a single-chamber ventricular transvenous pacemaker. No new device intervention is required, as the study relies on existing real-world data from these patients. The two groups serve as the study and comparator arms to assess differences in outcomes. Participants are followed using their medical claims and health records to monitor outcomes such as device-related complications within 30 days and survival after two years. Secondary outcomes include chronic device-related complications at six months and any device-related re-interventions within two years. The study began in June 2022 and will continue through 2028, tracking long-term safety and effectiveness measures without requiring new visits or procedures.

Researchers are collecting body materials and data from patients with or at risk of cardiac arrhythmias who have undergone or will undergo invasive or non-invasive treatments. The goal is to create a detailed collection of patient information to support research and improve understanding of the complex causes, varied clinical presentations, and outcomes of different arrhythmias. This effort aims to help identify patient subgroups for personalized treatment and prevention strategies. The study involves gathering bodily materials such as blood, left atrial appendage tissue, and various fat patches for biochemical marker assessments, histological, and molecular analyses related to cardiac arrhythmias. It includes patients participating in linked clinical trials and those undergoing cardiothoracic surgery. Different groups focus on specific types of arrhythmias, imaging studies, or tissue donations. Participants contribute clinical data and samples that are connected with their medical records for ongoing follow-up. Researchers monitor outcomes like new onset atrial fibrillation and recurrence of cardiac arrhythmia over a five-year period. The biobank supports long-term research by providing valuable materials and information to study the disease process and improve diagnosis, prevention, and treatment.

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing (VVI or VDD) according to clinical guidelines. This study aims to confirm the safety and performance of this device, including a special sub-study focusing on atrioventricular synchrony (AVS) performance. The trial is open-label, prospective, and involves multiple centers internationally, enrolling 325 participants. Participants will receive the LivIQ system, a single-chamber leadless pacemaker implanted directly into the right ventricle. The study involves a single arm where all subjects receive the device. The AVS sub-study collects specific data on AV synchrony using Holter monitors at 1 and 6 months. Follow-up visits are scheduled at implant, pre-discharge, 1 month, 3 months, 6 months, 12 months, then every 6 months until market approval. After U.S. approval, a remote 24-month visit will check vital status. During the study, participants undergo on-site exams, device performance checks, and questionnaires measuring quality of life and physical function. Researchers will monitor serious adverse device effects, pacing and sensing adequacy, battery longevity, and survival rates. The total participation will last until market approval with ongoing follow-up visits to ensure comprehensive safety and performance assessments.

Researchers are studying patients with heart failure (HF) who often experience irregular heartbeats called arrhythmias, including a common type called atrial fibrillation (AF). These arrhythmias can worsen heart failure, increasing the risk of strokes and death. While most knowledge comes from patients with devices like ICDs or CRTs, this study focuses on those who do not qualify for these devices. The goal is to better understand arrhythmias and worsening heart failure (WHF) in this group to help improve care. Participants receive a BIOMONITOR IV device, which is implanted and updated with special study software to collect detailed heart activity data remotely over a long period. The device also tracks fluid levels, breathing rate, and body position to provide more information that may predict WHF events. All participants use this investigational device throughout the study. During approximately 3.5 years of follow-up, researchers will monitor heart failure events confirmed by a committee and track arrhythmias and related treatments. Participants will attend follow-up visits in person and by phone, use a CardioMessenger device, and accept remote monitoring. The collected data will help develop a predictive algorithm for early intervention to reduce hospital visits and deaths related to worsening heart failure.