Atrial Flutter

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.

Researchers are evaluating two treatment approaches for patients with acute atrial fibrillation or atrial flutter when rhythm control is desired. The study compares conventional acute cardioversion performed within 48 hours in the emergency department to elective delayed cardioversion performed approximately one week later in an out-patient clinic. The goal is to see if these arrhythmias can be safely managed with an elective timing approach. Participants are randomly assigned to either immediate cardioversion in the emergency department or to an elective delayed cardioversion after discharge. All patients receive anticoagulation treatment according to guidelines, with extra precautions such as transesophageal cardiac ultrasound if needed before delayed cardioversion. Patients in the elective group can choose early cardioversion if symptoms become unmanageable before the scheduled out-patient visit. Participants undergo follow-up visits including a cardiologist assessment about one week after enrollment and further assessments one month later with an ECG to check heart rhythm. Quality of life and symptom monitoring occur during the first week and one month after the clinic visit. Patients are then followed up for up to five years to monitor any medical interventions related to atrial fibrillation or flutter. New antiarrhythmic drugs like flecainide are not used during the first month.

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.

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.

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 evaluating a new focal pulse ablation system for treating typical atrial flutter, a heart rhythm disorder. This prospective, single-group clinical study aims to assess the safety and effectiveness of this device in managing atrial arrhythmias. The study is sponsored by Hangzhou Dinova EP Technology Co., Ltd and focuses on patients who have experienced typical atrial flutter attacks recently recorded by ECG or Holter monitoring. The treatment involves a novel focal pulse field ablation device that performs a bidirectional block of the cavo-tricuspid isthmus (CTI). This procedure is intended to interrupt abnormal electrical signals causing atrial flutter. Participants will undergo the ablation procedure, and the study will monitor procedural success immediately afterward, as well as ablation efficiency factors such as procedure time and X-ray exposure. Participants will be followed up for safety and effectiveness over a period extending to six months post-procedure. Researchers will assess acute procedural success immediately after treatment and chronic success at six months. Safety monitoring includes tracking device-related major and severe adverse events within days and months after the ablation. The study involves clinical evaluations and imaging to ensure patient well-being and treatment monitoring.