Bad Neustadt An Der Saale

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercially approved Biosense Webster Inc. (BWI) medical devices used in standard cardiac arrhythmia mapping and ablation procedures. The study focuses on patients diagnosed with cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia. The goal is to confirm safety and performance of these devices in real-world use and to expand the evidence on their application in treating arrhythmias. Participants will be treated with commercially approved BWI medical devices following routine clinical practice. Sub-studies include participants treated with the Varipulse Catheter and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. No specific intervention or experimental procedure will be imposed for the study; the treatments follow standard care procedures. During the study, researchers will monitor safety by tracking adverse events related to the devices or procedures within seven days of treatment. They will also assess treatment effectiveness by evaluating specific outcomes such as isolation of pulmonary veins, non-inducibility of targeted tachycardias, and elimination of ventricular arrhythmias. Follow-up and compliance with standard hospital testing and care are expected as part of the participant involvement.

Researchers are collecting clinical data to assess the safety and performance of the Ankura™ TAA Stent Graft System and the Surpass Super Stiff Guidewire in patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD). The goal is to build clinical evidence on patient outcomes after using these devices. This multi-center, prospective, observational post-market follow-up study follows strict clinical protocols with oversight by an Ethics Committee. All participants will receive the Ankura™ TAA Stent Graft System implanted according to the device's instructions for use. The study monitors patients after implantation to evaluate device safety and effectiveness. The protocol requires no deviations except in emergencies, and all changes must be approved in writing. The study includes a 3-year follow-up period to track outcomes and complications. Participants will undergo regular assessments to monitor for major adverse events within 30 days after implantation and stent graft-related events up to 12 months post-implantation. Researchers will perform clinical evaluations, imaging, and laboratory tests as needed to track patient health and device performance. Safety monitoring continues throughout the study, ensuring thorough observation of all patients for up to three years after their procedure.

Researchers are evaluating the effectiveness and safety of adding oral anticoagulation (OAC) to standard antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. This phase 3, multicenter, open-label, randomized trial aims to compare the prevention of thromboembolic events like stroke or heart attack against the risk of major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two groups: the OAC-based strategy group receiving oral anticoagulants such as vitamin K antagonists or direct oral anticoagulants combined with antiplatelet therapy, or the control group receiving antiplatelet therapy alone with aspirin or a P2Y12-inhibitor. The anticoagulation treatment is given for 90 days, with the possibility for patients in the control arm who develop recurrent atrial fibrillation after 30 days to switch to anticoagulation. The study follow-up includes visits at 90 days and phone calls at 30, 60, and 180 days. Up to 500 patients may participate in a digital health substudy using a wearable heart rhythm monitor for 30 days after discharge. During the study, researchers will monitor participants for serious events such as death, ischemic stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization. Safety is assessed by tracking major bleeding events up to 90 days. Data from the registry group will be analyzed to compare risk profiles and treatment strategies. Participants will be evaluated through clinical visits, phone follow-ups, medical record reviews, and in some cases, digital monitoring to understand treatment effects and safety over time.

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, especially the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have previously experienced bleeding in the brain (intracranial bleeding) face challenges in treatment, as blood thinners can prevent clots but also increase bleeding risk. This research compares two approved treatment methods for such patients: a device to close the left atrial appendage (LAA) and oral blood-thinning medications (anticoagulants). One group of patients will receive a procedure to close the LAA using a device called Watchman or Watchman FLX, performed by skilled doctors under imaging guidance. After this procedure, patients usually take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may receive three months of oral anticoagulants followed by aspirin. The other group will continue oral anticoagulation therapy with medications that reduce stroke risk but have bleeding considerations. The study uses only approved devices and medications. Participants will be monitored for up to three years to track events such as cardiovascular death, stroke, embolism, and bleeding complications. Researchers will assess these outcomes to understand the benefits and risks of each treatment. The study aims to provide important data to guide doctors in managing atrial fibrillation patients with prior brain bleeding and to help reduce mortality and complications in this high-risk group.

Researchers are evaluating a new nationwide care model in Germany to improve how coronary computed tomography (coronary CT) is used for patients with new-onset stable chest pain suspected of having coronary artery disease (CAD). This study aims to optimize the implementation of coronary CT as a less invasive and more accurate alternative to cardiac catheterization, which is currently overused. The goal is to improve patient care while reducing cardiovascular events such as heart attacks and strokes, and to assess the impact on healthcare costs. The care model being tested focuses on better coordination between primary care doctors, radiologists, and patients. It includes evidence-based initial assessments, shared decision-making, and quality-assured CT imaging performed in certified centers. Participating sites receive structured training, feedback, and centralized quality monitoring to support this approach. This intervention will be applied across 16 regions in Germany over a 39-month period. Participants will be followed from enrollment through 12 months for the primary analysis of major adverse cardiovascular events (MACE), with extended follow-up up to 5 years to monitor cardiovascular death, heart attacks, and strokes. Researchers will collect data at 3, 12 months, and 5 years to evaluate the effectiveness of the new care model. This includes tracking patient outcomes, healthcare utilization, and cost savings, aiming to provide evidence for adopting this model nationwide if successful.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

This research aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III implantable cardiac monitors (ICMs) and their possible successors in real-life clinical settings. The study also serves as a platform for additional scientific and regulatory investigations with minimal extra effort for both clinical sites and patients. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, and cryptogenic stroke. Participants will receive a BIOTRONIK Implantable Cardiac Monitor and use the CardioMessenger device as part of the BIOTRONIK Home Monitoring system. The study observes routine clinical care with these devices and may include submodules for further research. The timeline includes monitoring the time to diagnosis starting from the device insertion. Throughout the study, participants will be regularly monitored using the implanted device and home monitoring technology. Researchers will track outcomes related to device performance, safety, and the time it takes to reach relevant diagnoses. Participants provide informed consent and agree to use the home monitoring system during the study period, contributing to long-term data collection and safety assessment.

Researchers are evaluating two medications, prednisolone and colchicine, for treating acute gout attacks, a common rheumatic disease where urate crystals cause severe joint pain. This study focuses on patients treated in general practice, including those with common health conditions often excluded in past research. The goal is to determine if prednisolone is comparable or only slightly less effective than colchicine in reducing pain during gout attacks. This phase 4 trial is conducted as a double-blind, randomized, controlled study across multiple university sites in Germany. Participants will be randomly assigned to receive either prednisolone or colchicine tablets for five days, with both groups also receiving placebo tablets to maintain blinding. The study uses the double-dummy method to ensure neither patients nor doctors know which treatment is given. Additionally, participants have the option to undergo a dual-energy CT scan of their feet to detect urate crystal deposits, which may provide insights into disease burden. During the study, patients will visit their general practitioner twice: once at the start and again after about one week. They will complete daily diaries tracking pain, joint swelling, tenderness, and any additional pain medication use for six days. Blood tests will check uric acid levels, inflammation, and kidney function. After four weeks, participants will be contacted by phone to assess recovery, recurrence, treatment, work incapacity, and side effects. The main measurement is the highest pain level reported on day 3 after starting treatment.

Researchers are investigating ways to prevent sudden cardiac death (SCD) in patients with poor heart function after a recent heart attack (myocardial infarction, MI). The trial evaluates if an electrophysiology study (EPS) can guide early implantable cardioverter-defibrillator (ICD) placement within the first 40 days after MI, a period when patients are at high risk but current guidelines do not recommend ICDs. The study also explores the use of cardiac MRI (CMR) to analyze heart function and predict dangerous heart rhythms early after MI. Participants will be randomly assigned to two groups. In the intervention group, all patients undergo an early EPS; those with a positive result indicating risk receive an ICD, while those with a negative result do not. The control group receives standard care, including discharge and heart function reassessment after 40 or 90 days, with ICD placement possible according to local guidelines. Some patients in both groups will have CMR to assess heart tissue and predict arrhythmias. Participants will be followed for two years to track sudden cardiac death and non-fatal arrhythmias like ventricular tachycardia or fibrillation. Researchers will also monitor overall survival, heart failure, repeat heart attacks, and ICD-related events. The trial aims to improve early identification and treatment of patients at risk for life-threatening heart rhythms, potentially changing future care guidelines.

Researchers are collecting real-world data on the hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A. This study focuses on patients who need replacement of their native or prosthetic aortic valve as the only heart valve procedure during their surgery. The aim is to understand the performance and effects of this valve in routine clinical practice. The study involves surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve. Up to 500 patients will be enrolled across up to 20 sites in Germany. The valve implantation is the main intervention, and patients may have other non-heart valve procedures alongside the surgery if applicable. The registry is observational, tracking outcomes following this surgical valve replacement. Participants will be followed with assessments including echocardiography and CT imaging before the procedure. Outcomes measured include the subject's average mean and peak pressure gradients across the valve, as well as the amount of aortic transvalvular and paravalvular regurgitation. These measures will be evaluated before discharge, about 7 to 10 days after surgery, and again at 3 months. Written informed consent and standard pre-procedure imaging data are required for enrollment.