Supraventricular Tachycardia (SVT)

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 AT—standard versus minimalized approaches—to 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 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 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 evaluating the Agilis Radiofrequency (RF) Transseptal System to study its initial safety and performance in crossing the atrial septum for accessing the left atrium and left ventricle during cardiac electrophysiology and interventional cardiology procedures. This early feasibility study involves a first-in-human, acute setting without long-term follow-up visits. The research aims to assess both safety and procedure success during hospital stay. Participants will undergo a transseptal procedure using the Agilis RF TSP System, which employs a radiofrequency wire to cross the atrial septum. The study focuses on an acute procedure setting with monitoring through hospital discharge, with no additional follow-up visits required. The procedure intends to facilitate access for left atrial and left ventricular interventions. During the study, participants will be observed from the time of device insertion through discharge from the hospital. Researchers will measure the rate of serious adverse events related to the device or procedure and the success rate of transseptal access as determined by the physician. The total participation time covers the procedure and hospital stay, with safety monitored periprocedurally.

This research investigates the Willem™ AI-powered ECG analysis platform designed to detect arrhythmias and abnormal cardiac patterns in high-risk cardiac patients. The study aims to evaluate whether this AI tool can classify and predict arrhythmic episodes at the level of a cardiologist and potentially delay or prevent serious cardiac events like sudden death. The study includes patients with cardiac arrhythmias or abnormal ECG patterns and requires at least one ECG record with over one year of follow-up data. The study is observational and multicenter, comparing AI-driven ECG analysis with expert cardiologist diagnoses. Patients are divided into a training group, where new algorithms are developed, and a test group, which evaluates these algorithms to avoid overfitting. The platform analyzes electrical cardiac signals lasting 10 seconds or more from various medical devices, including hospital 12-lead ECGs, telemetries, Holter monitors, wearable ECG devices, and mobile telemetry patches. Participants will provide ECG data and clinical information, which expert cardiologists will label for arrhythmias. The study tracks outcomes such as arrhythmia detection time (from real-time to 7 minutes), survival, major adverse cardiovascular and cerebrovascular events, rehospitalization, and quality of life over one year after the first ECG or enrollment. Consent is required, and patients unable to consent may have a relative provide it. The study will assess the AI platform's accuracy, sensitivity, and specificity in detecting cardiac abnormalities.

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 collecting clinical data to assess the ongoing safety and performance of commercial Biosense Webster Inc. (BWI) medical devices used during routine cardiac arrhythmia mapping and ablation procedures. The study focuses on patients with cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. This observational post-marketing study aims to confirm the safety and performance of these devices in real-world settings and expand knowledge about their use in treating arrhythmias. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure will be observed while treated with commercially approved BWI devices such as the BWI therapeutic catheter, Varipulse Catheter, or Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. These devices are used according to routine clinical practice without a specific intervention dictated by the study. Sub-studies include participants treated with the Varipulse Catheter (VARIPURE) and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter (DUACURE). During the study, participants will be monitored for safety and effectiveness outcomes, including adverse events related to the device or procedure within 7 days and up to 365 days after treatment. Measurements include success rates in isolating targeted pulmonary veins, achieving non-inducibility of tachycardias, freedom from arrhythmia episodes, and rates of repeated ablation. Data collection aligns with standard hospital care and includes follow-up assessments over one year, providing comprehensive information on device performance and patient outcomes.

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.