Atrioventricular Block (AV Block)

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 chronic heart failure patients who have a specific heart conduction problem called nonspecific intraventricular conduction delay (NICD). This randomized, controlled trial aims to compare the effects of a newer pacing method called left bundle branch area pacing combined with left ventricular pacing (LOT-CRT) against the traditional biventricular pacing (BiVP) method. The goal is to see which method better preserves heart function in patients with NICD over a follow-up period of at least six months. Participants will be randomly assigned to one of two groups. In the LOT-CRT group, patients receive a right atrial lead, an implantable cardioverter defibrillator lead, a left ventricular pacing lead, and a left bundle branch area pacing lead. The BiVP group receives the same leads except for the left bundle branch area pacing lead. The study will follow participants for a minimum of six months to compare the effects of these pacing methods on heart function and clinical outcomes. During the study, participants will undergo assessments including echocardiograms to measure left ventricular ejection fraction at baseline and six months. Other evaluations include paced QRS durations, heart function classifications, quality of life questionnaires, walking tests, blood tests for heart failure biomarkers, and monitoring of arrhythmias and hospitalizations. Researchers will also track the success rate of the left bundle branch area pacing implantation. Safety and clinical outcomes will be closely monitored throughout the study, which is expected to last over three years for recruitment and follow-up.

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 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 investigating how accurately a smartwatch can detect heart rhythm and conduction problems in patients with cardiovascular diseases. This observational study compares the heart readings from a smartwatch to those from a traditional 12-lead electrocardiogram (ECG) to see how similar the results are and how well the smartwatch's automatic diagnosis matches expert assessments. The study aims to improve early detection and monitoring of heart conditions to prevent serious health issues. Participants will have their heart activity recorded using an Apple Watch Series 4 and a conventional ECG device. The smartwatch will record two 30-second ECG tracings while the patient is at rest, attached to the left wrist with the right hand touching the sensor to complete the measurement. The conventional ECG will capture 12 leads including a 30-second rhythm trace. The smartwatch's automatic diagnoses will be compared with the conventional ECG results and interpreted by two independent cardiologists. During the study, participants provide clinical and demographic information and undergo both smartwatch and conventional ECG recordings. The researchers will analyze the similarity of heart rate, waveforms, and intervals between methods, along with the diagnostic accuracy of atrial fibrillation and other heart rhythm disorders. The main outcome is the agreement between the smartwatch and conventional ECG diagnoses. Safety and data quality will be monitored, and participants may withdraw at any time without affecting their medical care. The total study duration is around 30 days for outcome assessment.

Researchers are evaluating an investigational artificial intelligence (AI) software designed to estimate the severity of ejection fraction (EF), which indicates how well the heart pumps blood. This prospective, multicenter, cluster-randomized controlled study compares EF severity categories determined by the AI software using continuous ECG waveform data to those measured by an FDA-cleared transthoracic echocardiogram (TTE). The study aims to provide a low-burden, cost-effective alternative for EF monitoring in heart failure and related heart conditions, especially where traditional imaging access is limited. Participants will use the FDA-cleared Peerbridge COR4 ECG Wearable Monitor, a patch device worn during daily activities, to collect ECG data. During a 15-minute resting session while seated upright, 5-minute ECG segments will be recorded and analyzed by the AI software to estimate EF severity based on the American Society of Echocardiography's scale. The study includes two subprotocols: one with 30 minutes of ECG recording including 15 minutes analyzed, and another allowing up to 7 days of device use with periodic sitting sessions. The EF severity from the AI software will be compared against results from echocardiography. Participants will be enrolled at multiple sites, providing paired data points consisting of simultaneous or near-simultaneous ECG recordings and echocardiograms. They will follow a standardized 15-minute seated session protocol using the wearable device, pressing an event button to mark the session start and end. Data collection includes medical histories, 12-lead ECGs, and device logs. The main outcome measures focus on agreement between the AI software's EF severity categories and those from echocardiography over an average of 9 months. Safety and compliance will be monitored throughout the study period.

Researchers are studying patients who undergo transcatheter aortic valve implantation (TAVI) and develop a new, persistent left bundle branch block (LBBB), a heart conduction problem. The study aims to find out how often and when serious types of atrioventricular block (AVB) occur in these patients and to identify predictors of this condition. They are also evaluating the use of the Reveal LINQae insertable cardiac monitor to detect important heart rhythm problems in this group. After TAVI, patients are monitored with ECG during their hospital stay, with daily ECGs until discharge. Those with persistent new-onset LBBB lasting at least 48 hours and still present at discharge receive an implantable loop recorder device (Reveal ICM LINQae) placed under the skin to continuously record heart activity. Follow-up visits are scheduled at 1, 12, 24, and 36 months after the procedure, with additional visits if symptoms or significant arrhythmias develop. The device is checked manually during these visits, and phone follow-ups occur every three months. Participants will undergo regular outpatient assessments including device interrogation, symptom evaluation, and ECG monitoring. The study measures include the rate and timing of high-degree or complete AVB, arrhythmic events detected by the device leading to treatment changes or adverse events, and changes in heart function over up to three years. The total participation duration can be up to 36 months with ongoing safety and clinical monitoring.

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.

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.