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 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 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.

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.