Pacemaker

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

Researchers are studying pacing-induced cardiomyopathy (PICM), a condition where chronic right ventricular pacing harms left ventricular function. This observational study focuses on ECG and echocardiogram parameters, including strain, as well as genetic factors, to identify patients at high risk of developing PICM after pacemaker implantation. The goal is to better predict who might develop PICM and understand its clinical impact over time. Participants will have ECG and echocardiogram tests before and after pacemaker implantation to assess key measurements such as QRS duration and mechanical strain. Genetic factors may also be evaluated to improve prediction of PICM occurrence. This study involves long-term follow-up to monitor the condition and its outcomes. During the study, participants will be clinically followed for up to 5 years to observe heart failure diagnosis and treatment. Researchers will also track atrial and ventricular arrhythmias, hospital admissions for heart failure, and overall mortality. The study does not involve treatment interventions but focuses on monitoring and data collection to understand PICM and its clinical outcomes.

Researchers are evaluating the safety and effectiveness of the AVEIR VR LP and AVEIR AR LP leadless pacemaker systems in patients who need pacemakers in France. This national registry study, called "France LEADLESS," aims to confirm how these devices perform under normal conditions in patients needing VVI(R), AAI(R), or DDD(R) pacemakers, and to collect information about patient characteristics and device indications. The study is observational, retrospective and prospective, and non-randomized, following patients who have received these devices. Participants in this registry have been or will be implanted with the AVEIR VR LP or AVEIR AR LP devices, either individually or used together. The study monitors the devices over time, focusing on their safety and effectiveness up to 24 months after implantation. Secondary measures include tracking device stimulation thresholds, detection, atrioventricular synchronization, and remaining service life over 36 months. The study involves no experimental treatments but follows real-world use of these leadless pacemakers. During the study, patient data and device performance are collected and monitored regularly for up to three years after implantation. Researchers evaluate safety and effectiveness outcomes and gather detailed patient and device information. Participants are followed to confirm how well the devices work and to monitor any changes or issues over time. The total participation duration can extend to 36 months after device implantation, allowing long-term observation of device function and patient status.

Atrial fibrillation (AF) is a common heart rhythm problem, and its occurrence is increasing. Many patients with persistent AF do not respond well to ablation treatments or are not suitable for them due to age, other health issues, or previous unsuccessful procedures. Since controlling heart rhythm does not improve survival compared to rate control, some patients undergo AV node ablation and pacemaker implantation to manage symptoms. This study focuses on comparing a new pacing method called HIS bundle pacing to the standard right ventricular pacing in patients with AF who show signs of heart failure. Participants will be randomly assigned to receive either right ventricular (RV) pacing or HIS bundle pacing (HBP). All will have a pacemaker implanted with a lead in the right ventricle, but only those in the HBP group will have an additional lead on the HIS bundle to stimulate the heart more naturally. AV node ablation will be performed either during the same procedure or within 4-6 weeks. The study uses a double-blind design, with follow-up evaluations at baseline, 4 weeks, 6 months, and 12 months, after which participants and assessors are unblinded. During the year-long study, participants will be monitored for improvements in walking ability, heart function through echocardiograms, heart failure hospitalizations, and pacemaker performance. Activity will be tracked using a Fitbit smartwatch to measure daily steps and walking distance. Safety will be assessed by monitoring for infections, lead problems, and the need for additional procedures. The trial aims to determine if HIS bundle pacing offers advantages over traditional RV pacing for these patients.

Researchers are exploring how deep brain nuclei activity and the cerebral cortex function during recovery from general anesthesia in patients undergoing deep brain stimulation (DBS) surgery. This study aims to understand the changes and connections between deep brain nuclei firing and cortical activity during the return of consciousness. The research focuses on the brain's neural networks involved in recovery, which is not just a passive drug clearing process but an active brain function. During the study, patients having DBS surgery will have their local field potentials (LFP) from deep brain nuclei and scalp electroencephalograms (EEG) from the frontal cortex recorded simultaneously. No additional interventions are given beyond the planned DBS surgery. These recordings occur during the recovery period after general anesthesia to analyze how signals from deep brain areas relate to cortical EEG activity. Participants will be monitored for changes in brain signals over about 2 hours during recovery from anesthesia. Researchers will evaluate the number of patients showing changes in LFP and EEG patterns. The study includes assessments of brain activity to better understand consciousness recovery mechanisms. Patients are expected to cooperate during surgery and recording, with the total observation focused on the immediate post-anesthesia recovery phase.

Researchers are evaluating the Turkish version of the Assessment of Quality of Life and Related Events (AQUAREL) scale specifically for patients with pacemakers. Cardiac implantable electronic devices, such as pacemakers, are commonly used to reduce serious heart rhythm problems and sudden cardiac death, but they can lead to complications that affect patients' quality of life. This study aims to test the validity and reliability of this Turkish adaptation to ensure it accurately measures quality of life in this patient group. The study involves patients who have pacemakers without current complications and covers those in all New York Heart Association (NYHA) classes I through IV. Participants will be observed over a one-year period, during which the Turkish AQUAREL scale will be applied and evaluated. The study focuses on assessing patients' quality of life, daily living activities, and comorbidity levels to understand the scale's effectiveness in this context. Participants will be monitored with scheduled assessments over the course of one year to measure quality of life using the adapted scale. Researchers will evaluate various outcomes including quality of life, daily activity levels, and comorbidity status. This observational study does not involve interventions but collects data to validate the scale's use for Turkish-speaking pacemaker patients, contributing to improving patient care and monitoring in clinical settings.

Congenital heart disease (CHD) affects about 1% of newborns in the US, with many needing open heart surgery in their first year. As patients with CHD live longer, atrial arrhythmias like sinus node dysfunction and intra-atrial re-entrant tachycardia (IART) are common complications. This research aims to evaluate how effective atrial anti-tachycardia pacing (ATP) therapy is for treating IART in different groups of CHD patients, including comparisons between adults and children. The study uses data from past and ongoing patient records to better understand ATP outcomes in this population. Participants have implanted pacing devices that deliver ATP therapy to manage their arrhythmias. The study collects data both retrospectively and prospectively from electronic medical records and pacemaker device checks. Patients are enrolled when their ATP device is implanted or activated, and data includes at least five years of clinical history before and after device use when possible. No new treatments are given since this is an observational study focusing on how well ATP works and any adjustments made to device programming. During the study, participants will have clinical evaluations and follow-up visits every 3 to 6 months. Researchers will assess arrhythmia burden, medication use, and device settings to measure changes before and after ATP therapy. The main outcome is the change in IART burden over at least five years. The study also looks at medication needs and compares different ATP programming methods. Safety and long-term effects are monitored through ongoing clinical data collection until the study ends in 2027.

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.