Bradycardia

Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

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 VVIR, AAIR, or DDDR 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.

Researchers are evaluating the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH SF catheter combined with the TRUPULSE generator for treating ventricular arrhythmias. This study focuses on whether the abnormal heart rhythms, including premature ventricular complexes and sustained monomorphic ventricular tachycardias, can be successfully treated using a specific procedural workflow during cardiac ablation. The trial also monitors participant safety by checking for any complications after the procedure. Participants undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, which delivers radiofrequency and pulsed field energy mainly as RFPF stacking applications according to the studys procedural workflow. The study groups include those being treated for premature ventricular complexes and different types of sustained ventricular tachycardia. The study tracks the procedures effectiveness and safety over several months following the ablation. During the study, participants are monitored with assessments including electrocardiographic data review, tracking of adverse events up to six months post-procedure, and intraoperative measurements such as procedure time, mapping details, and ablation parameters. Researchers measure the success of the procedural workflow at 3 months for premature ventricular complexes and at 6 months for ventricular tachycardia cases. Safety is closely observed up to 7 days and 6 months after the ablation to detect any adverse effects or complications.

Researchers are evaluating the usability of the WearLinq eWave patch, a wearable multi-channel ECG monitoring device, in a general adult population. The study includes healthy adults as well as those with heart disease, arrhythmia, or other cardiac conditions. The goal is to understand how well participants can use this device and to monitor its wear duration and any adverse events during usage. Participants will apply the WearLinq patch continuously for 7 consecutive days in the primary study group. A smaller group of participants will be asked to use the patch for an extended period of 30 consecutive days. The patch continuously tracks cardiac rhythm by monitoring electrical activity from the chest area. During the study, participants will be monitored for how long they wear the device and for any adverse effects related to its use. Researchers will collect data on device adherence and safety outcomes over the wear periods. The total study duration for participants varies depending on whether they are in the 7-day or 30-day use groups, with all assessments focused on supportive care and device usability.

Researchers are studying atrial tachycardia AT that occurs after ablation of atrial fibrillation AF or cardiac surgery. This condition is difficult to treat due to the complex nature of the heart tissue and the mechanisms causing AT. The study aims to compare two methods of catheter ablation for ATstandard versus minimalized approachesto see which leads to better arrhythmia-free survival. The trial is prospective, randomized, and conducted at multiple centers to improve understanding using new ultra-high-density mapping techniques. Participants will receive catheter-based ablation using radiofrequency to treat their AT. They will be randomly assigned to either a standard ablation approach or a minimalized ablation approach targeting the clinical AT. The study will evaluate various procedural details such as procedure duration, fluoroscopy time, radiofrequency application time, ablated heart area, and the number of blocked lines. Both groups will be monitored during the procedure with advanced mapping techniques to assess the underlying heart substrate and AT mechanisms. During the study, participants will undergo assessments including ECG documentation of AT, intraprocedural mapping, and evaluations of arrhythmia recurrence over one year. Researchers will measure the recurrence of sustained arrhythmia lasting more than 30 seconds as the primary outcome after one year. Other measures include inducibility of AT after ablation, predictability of secondary AT from mapping, and procedure-related parameters. Participants will be followed for safety and treatment effectiveness throughout the study period, which started in December 2020 and is expected to continue until June 2027.

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 smartwatchs 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 smartwatchs 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 studying patients with non-valvular atrial fibrillation who are scheduled to have a combined procedure involving atrial fibrillation ablation and left atrial appendage LAA occlusion. This prospective, multi-center, randomized controlled trial aims to compare two methods for selecting the size of the LAA occluder device during the procedure. The study is sponsored by the First Affiliated Hospital of Shantou University Medical College and seeks to evaluate the accuracy of size selection using two imaging approaches. Participants are randomly assigned to one of two groups the CT group, where the LAA occluder size is chosen based on preoperative cardiac CT measurements, and the DSA group, where size selection is guided by intraoperative digital subtraction angiography DSA measurements. Both methods are used after completing the atrial fibrillation ablation. The trial measures various outcomes including the accuracy of occluder size selection during the procedure, procedural success, procedure-related times, and incidence of major adverse events within three months after the procedure. Participants will have clinical follow-ups before hospital discharge and at three months after surgery, with telephone follow-ups conducted annually for up to five years. The study monitors procedure success, device-related leaks at three months, and any major adverse events related to the device or procedure. The total participation duration can extend up to five years, allowing careful assessment of both immediate and longer-term outcomes.

Atrial fibrillation AF is the most common heart rhythm disorder worldwide, affecting about 3% of adults and expected to increase due to longer lifespans and more diagnoses. This study aims to prospectively evaluate a large group of patients undergoing AF ablation to identify clinical and procedural factors that predict success in preventing arrhythmia recurrence over the medium to long term. The main goal is to determine which parameters best predict freedom from clinical atrial arrhythmias 12 months after the procedure. Patients with indications for AF ablation will receive treatment following standard care at participating centers. The study collects data on procedural success immediately after ablation and tracks patients for 12 months to monitor for arrhythmia recurrence, other atrial arrhythmias, and any adverse events. The study will also assess patient-reported outcomes, ECG changes before and after ablation, and healthcare resource use. This observational study enrolls consecutive patients meeting eligibility criteria without altering their treatment plan. Participants will be followed for 12 months after their ablation procedure, with data collected on clinical history, drug therapy, arrhythmia recurrences, adverse events, and patient symptoms. Evaluations include acute procedural success, ECG monitoring, and questionnaires on quality of life and symptom severity. Researchers will analyze these data to identify factors associated with long-term success and safety of AF ablation. This study provides real-world insights into the management and outcomes of patients undergoing AF ablation over time.

Researchers are conducting an observational study called ELDORA to develop and validate artificial intelligence AI tools that analyze electrocardiogram ECG data for detecting life-threatening heart rhythm problems, such as Torsades-de-Pointes and immune checkpoint inhibitor-induced myocarditis. This project focuses on standardizing diverse ECG records from both analog and digital sources and aims to support clinical research in predicting risks related to these conditions. The study consolidates ECG data and clinical information from about 49 national and international cohorts, gathering roughly 127,000 subjects and up to 10 million ECG recordings. These datasets include a wide range of health conditions and populations, including healthy volunteers, patients with long QT syndrome or cancer treated with immune therapies, and those with cardiovascular or metabolic disorders. The ECG data will be harmonized into a unified database called ECGInsight, and AI models will be trained and evaluated using this comprehensive resource. Participants are involved through their existing ECG data and clinical records no treatments or interventions are assigned during the study. Researchers will assess AI model performance using various metrics like accuracy, sensitivity, specificity, and others throughout the study period, which is anticipated to last up to 48 months. The study complies with data protection regulations and uses de-identified information, with no direct impact on patient care during the research.