Ventricular Fibrillation

Researchers are evaluating the potential benefits of implanting an implantable cardioverter defibrillator ICD in patients with coronary artery disease who have survived cardiac arrest caused by ventricular fibrillation or sustained ventricular tachycardia. These patients have undergone complete revascularization and have a left ventricular ejection fraction LVEF above 35%. The study aims to assess whether ICD implantation can improve survival outcomes compared to standard medical therapy. Participants are randomly assigned to one of two groups one group receives an ICD implanted either during admission or within 4 weeks after discharge from the initial cardiac event, while the other group receives guideline-directed medical therapy without ICD implantation. The study compares these approaches to understand the effect of ICDs on survival in this patient population. During the study, participants will be monitored for outcomes including all-cause mortality over a five-year period, as well as mortality related to cardiovascular causes at one year. Researchers will collect data on sudden cardiovascular death and cardiovascular death within the first year. The trial includes follow-up assessments to track these outcomes and the overall health of participants throughout the study duration.

This trial investigates cardiac arrest treatment by comparing standard Advanced Cardiovascular Life Support ACLS alone to ACLS combined with aortic balloon occlusion ABO using the NEURESCUE device. The study aims to evaluate the clinical safety and performance of adding ABO, an emergency method that quickly directs blood flow to the heart and brain during cardiac arrest, potentially improving outcomes. Participants are randomly assigned to one of two groups one receiving standard ACLS treatment, which includes CPR, airway management, ventilation, and defibrillation, and the other receiving ACLS plus ABO using the NEURESCUE device. The NEURESCUE catheter is inserted via the femoral artery into the descending aorta and temporarily inflates a balloon to redirect blood flow. The NEURESCUE Assistant controls pressure-regulated inflation and deflation of the balloon during treatment. Throughout the study, cardiac rhythm and return of spontaneous circulation are closely monitored. Participants will have four visits, including a 90-day follow-up to assess outcomes. Researchers will measure resuscitation success, epinephrine use, procedures, adverse events, neurological function via CPC score, quality of life with EQ-5D, and survival. The study runs from randomization through 90 days post cardiac arrest to evaluate safety and performance.

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 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 adult patients who have experienced out-of-hospital cardiac arrest OHCA and remain unconscious after resuscitation. This observational substudy, part of the larger STEPCARE Trial, aims to compare a new algorithm-based EEG index called the C-Trend Index with traditional visual analysis of continuous EEG cEEG recordings. The goal is to see which method better predicts patients functional outcomes six months after the cardiac arrest, focusing on early EEG data collected 9 to 12 hours after the return of spontaneous circulation ROSC. Participants are adults who have had OHCA and sustained ROSC but remain comatose. They are enrolled in the STEPCARE Trial and monitored using the Brainstatus device to collect cEEG data. The C-Trend Index is recorded continuously and analyzed retrospectively without affecting patient care or clinical decisions. The study compares the predictive accuracy of the C-Trend Index and visual EEG analysis, assessing favorable outcomes defined by a modified Rankin Scale score. Secondary aims include evaluating different cut-off values of the index and how other STEPCARE Trial interventions may influence its accuracy. During the study, EEG data is collected at least 24 hours after inclusion or until the patient awakens. Researchers assess the EEG recordings from the 9-12 hour window after ROSC to measure the primary outcome of functional status six months later. The study involves monitoring and analysis of EEG patterns and the C-Trend Index, with blinded outcome assessors evaluating patient recovery. The study plans to enroll around 300 patients to ensure enough data, accounting for potential early recovery or data loss.

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 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.

The WILLEM study is a multicenter observational trial focusing on high-risk cardiac patients with arrhythmias or abnormal ECG patterns. It aims to validate a cloud-based AI-powered ECG analysis platform called Willem173, which is designed to detect and predict cardiac abnormalities. The study compares the AI diagnoses with cardiologists evaluations and assesses the platforms ability to delay or avoid severe cardiac events such as sudden death. Participants include patients with relevant cardiac arrhythmias or diseases and at least one ECG record with over one year of follow-up data. Participants are divided into two groups a training group to develop new AI methodologies and a test group to evaluate the AIs performance and avoid overfitting. The AI platform analyzes cardiac electrical signals lasting 10 seconds or more, collected from various devices including hospital ECG machines, Holter monitors, wearable ECG patches, and telemedicine interfaces. Cardiology experts review all data to label arrhythmias and patterns. Both retrospective and prospective patient data are used. During the study, participants provide ECG data and clinical information for analysis. Researchers monitor primary outcomes such as real-time detection of cardiac arrhythmias within minutes of ECG recording. Secondary outcomes include survival, major cardiovascular events, rehospitalization, and quality of life measured one year after the initial ECG or enrollment. Informed consent is obtained from patients or authorized relatives if patients cannot consent themselves. The study is conducted until November 2026, with ongoing data collection and evaluation.