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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 collecting clinical data to evaluate the ongoing safety and performance of commercial Biosense Webster Inc. BWI medical devices used during routine cardiac arrhythmia mapping and ablation procedures. This observational study aims to confirm the safety and effectiveness of these devices after they have been approved for market use, expanding knowledge on their role in treating cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure using BWI therapeutic catheters, including Varipulse and Dual Energy THERMOCOOL SMARTTOUCH SF catheters, will be observed during their routine clinical treatment. The study does not introduce additional interventions but monitors standard procedures using these commercial devices. Sub-studies involve participants treated specifically with the Varipulse or Dual Energy catheters. During the study, participants will be monitored for adverse events related to the devices and procedures within 7 days post-procedure and up to one year for serious or non-serious adverse events. Effectiveness measures include arrhythmia isolation or elimination and freedom from arrhythmia episodes over time. Data collection aligns with routine care standards, including follow-up visits up to 365 days to assess outcomes such as arrhythmia recurrence, repeated ablations, hospitalizations, and mortality. The study duration extends through December 2037.

This research aims to assess the effectiveness and safety of adding oral anticoagulation OAC to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC to evaluate the prevention of thromboembolic events and the risk of major bleeding. Participants are randomly assigned to either an OAC-based strategy using vitamin K antagonists or approved direct oral anticoagulants alongside antiplatelet therapy, or to an antiplatelet-only strategy. The anticoagulation treatment lasts for 90 days, with option for crossover to OAC if recurrent atrial fibrillation occurs after 30 days in the control group. Up to 500 patients may also participate in a digital health substudy using a wearable heart rhythm monitor for 30 days post-discharge. During the study, participants have follow-up visits at 30, 60, 90, and 180 days after randomization, including phone contacts and clinical assessments. Researchers will monitor outcomes such as death, stroke, transient ischemic attacks, myocardial infarction, thromboembolism, and bleeding events up to 180 days. Data from patients who decline randomization are collected in a parallel registry to compare baseline risk and treatment strategies.

Researchers are investigating sovateltide as a new treatment for acute cerebral ischemic stroke, a condition caused by a blockage in blood flow to the brain leading to tissue damage. This trial follows promising results from earlier studies in animals and humans showing sovateltides potential to improve neurological outcomes. The goal is to evaluate the safety and effectiveness of sovateltide combined with standard care for stroke patients in the United States and other countries. Participants will receive either sovateltide or normal saline as a placebo, both given as intravenous bolus doses within 24 hours of stroke onset. Three doses are administered on day 1, then repeated on days 3 and 6. The study is randomized, double-blind, and placebo-controlled, ensuring unbiased comparison between the treatment and control groups. During the study, patients will be monitored for neurological function and recovery using scales like the modified Rankin Scale, NIH Stroke Scale, and Barthel Index up to 90 days after treatment. Additional assessments include quality of life questionnaires, cognitive tests, and imaging to detect any complications. Safety is closely tracked throughout the study, which lasts about three months from treatment to final evaluation.

Atrial fibrillation is the most common heart rhythm disorder, increasing the risk of blood clots forming in the heart, especially in the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have had an intracranial bleed bleeding in the brain are often treated with blood thinners to prevent stroke, but these medications can increase bleeding risk. This study compares two treatment methods to prevent strokes in such patients blood thinners and a device that closes off the left atrial appendage of the heart. The study randomly assigns participants to one of two groups. One group receives a device called Watchman or Watchman FLX to close the left atrial appendage through a minimally invasive procedure, followed by short-term blood thinning medication. The other group receives standard oral blood thinners as per current guidelines. Only approved drugs and devices are used. The trial aims to provide data to help doctors manage patients with atrial fibrillation who have experienced brain bleeds. Participants are followed for up to three years after randomization. Researchers monitor for events such as death from cardiovascular causes, stroke, systemic embolism, and bleeding episodes. Assessments include imaging during the procedure and regular follow-up visits to track health outcomes. The main measure is event-free survival without these complications. This long-term follow-up helps evaluate the safety and effectiveness of each treatment approach in preventing strokes and bleeding.

Researchers are studying dementia and mild cognitive impairment in Bavaria, focusing on people living at home with these conditions and their family caregivers. This study aims to improve understanding of the complexity, progression, and care needs of dementia in both urban and rural areas. The research includes people with mild cognitive impairment and mild to moderate dementia as defined by ICD-10 codes and is conducted through a multicenter, prospective, longitudinal registry. Participants include those with mild cognitive impairment or dementia and their family caregivers. Before joining, cognitive tests such as the Mini Mental State Examination and Montreal Cognitive Assessment are used to assess suitability. Participants are interviewed face-to-face at the start, after 6 months, 12 months, and then annually. Recruitment is through various institutions involved in dementia care, including clinics, counseling centers, and outpatient and inpatient facilities across Bavaria. During the study, participants provide detailed information on demographics, health, social and care situations, cognitive assessments, and quality of life measures at multiple timepoints over several years. Researchers collect data on medical history, medication use, cognitive function, social support, internet use, mobility, caregiver burden, and more. This long-term observation helps track changes and care needs up to ten years, with regular follow-up interviews and assessments throughout the study.

Researchers are investigating a new nationwide care model called NVF to improve the diagnosis and treatment of patients with recent-onset stable chest pain and suspected coronary artery disease CAD in Germany. This study aims to enhance the use of coronary computed tomography CT as an alternative to cardiac catheterisation, potentially reducing cardiovascular events like heart attacks and strokes while lowering healthcare costs. The trial is a pragmatic, cluster-randomised stepped-wedge design conducted in 16 regions across Germany. Participants will be assigned to one of two groups usual care following national guidelines without structured coordination, or the IMPRO cross-sectoral care model that connects general practitioners with certified cardiac CT centres. The IMPRO program includes evidence-based initial assessments, shared decision-making among doctors and patients, quality-assured CT imaging, structured reporting, and ongoing training and quality monitoring at participating sites. This intervention is designed to improve diagnostic accuracy and care coordination. During the study, participants will be monitored for major adverse cardiovascular events MACE such as cardiovascular death, myocardial infarction, or stroke over 12 months, with extended follow-up up to 5 years. Researchers will also track procedure-related complications, test rates, hospitalizations, emergency visits, radiation exposure, quality of life, angina symptoms, and medical costs. Data collection includes baseline and follow-up assessments at 3 months, 12 months, and 5 years to evaluate clinical outcomes, safety, cost-effectiveness, and patient quality of life.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

This research aims to evaluate the long-term outcomes, performance, and ongoing safety of the BIOMONITOR III and its possible successors in everyday clinical use. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, or cryptogenic stroke. The study is designed as an observational registry, allowing additional scientific investigations with minimal extra effort for participants and study sites. Participants will receive a BIOTRONIK Implantable Cardiac Monitor ICM and will use the CardioMessenger device to support the BIOTRONIK Home Monitoring system. The registry monitors patients under routine clinical care without introducing experimental treatments or interventions. Data collection includes the insertion procedure and success rate of the device, as well as the time taken to reach a relevant diagnosis starting from device implantation. Throughout the study, participants will be observed during their regular clinical care visits. Researchers will collect information on device performance, safety, and diagnostic timelines. The study will continue until August 30, 2027, tracking patient outcomes over this extended period. Participation involves consenting to the use of home monitoring technology and agreeing to data collection related to the implanted device and clinical events.

Researchers are evaluating ways to prevent sudden cardiac death in patients with poor heart function after a heart attack myocardial infarct. The trial compares the use of an electrophysiology study EPS to guide early implantable cardioverter-defibrillator ICD implantation within 40 days after a heart attack, against standard care. The study also examines whether cardiac MRI CMR can predict dangerous heart rhythms and assess heart tissue damage early after a heart attack. Participants are randomly assigned to one of two groups. In the intervention group, all patients receive an early EPS those with certain types of inducible heart rhythms receive an ICD implant, while others do not. The control group receives standard care, which may include ICD implantation after 40 or 90 days if indicated by current guidelines. Some patients in both groups will have a CMR scan more than 48 hours after revascularization to study heart function, scarring, and tissue health. Participants will be followed for 2 years to monitor for sudden cardiac death or non-fatal heart rhythm problems, which is the main outcome. Other outcomes include overall survival, heart failure, repeat heart attacks, and issues related to ICD use. The study collects detailed heart rhythm and imaging data to better understand risks and improve treatment decisions for patients after a heart attack.