Bad Segeberg

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 evaluating the safety and effectiveness of a shorter dual antiplatelet therapy (DAPT) using Prasugrel followed by Prasugrel alone compared to the standard one-year DAPT regimen in patients who have experienced ST Elevated Myocardial Infarction (STEMI). The study also compares two methods for guiding complete revascularization of non-culprit lesions in patients with multivessel disease: one using Optical Coherence Tomography (OCT) and the other using standard angiography. The study involves treating STEMI patients with a loading dose of Aspirin and Prasugrel, followed by treatment of the culprit lesion during the initial procedure. In patients with multivessel disease, non-culprit lesions will be treated in staged procedures within 15 days. These patients will be randomly assigned to either OCT-guided or angiography-guided revascularization. After 30 to 45 days, if they meet certain criteria, patients will be randomized to receive either Prasugrel monotherapy or continue the standard DAPT regimen. Participants will be followed for 35 months after randomization to monitor clinical outcomes at 11 and 35 months. Researchers will assess the success of the revascularization procedures, adherence to treatment, and any significant cardiovascular events. The study measures include the safety and efficacy of the shorter DAPT regimen and the effectiveness of OCT-guided versus angiography-guided revascularization immediately after the procedure.

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.

Researchers are evaluating the safety and effectiveness of robotically assisted percutaneous coronary intervention (PCI) using the CorPath GRX System in treating patients with coronary artery disease, including stable conditions, unstable angina, and acute myocardial infarction. This retrospective registry collects data from real-world clinical practice across Europe and Asia to better understand this innovative robotic approach. The study focuses on the use of the CorPath GRX System, a robotic platform designed to assist with the remote delivery and manipulation of guidewires, catheters, and guide catheters during PCI procedures. It includes a bedside robotic arm and a remote workstation, which together provide automated movements intended to improve procedural success, reduce procedure time, and enhance operator comfort. Patients included are those who underwent at least one robotic procedural step with this system and have completed one-year follow-up. Participants will have their baseline, procedural, and follow-up data collected to assess outcomes such as the number of participants with clinically successful PCI from the time of the procedure until hospital discharge or death. The study plans to enroll at least 700 patients, monitoring safety and efficacy through this comprehensive data collection over a one-year period after the intervention.

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.

Researchers are conducting a registry to study the performance and short-term safety of Resorbable Magnesium Scaffolds (RMS) in patients with coronary artery disease. This registry follows the ESC/EACTS guidelines and evaluates these devices in real-world use based on their intended instructions without additional medical exclusion criteria. The study involves the use of two types of RMS devices, Magmaris and Freesolve, which are designed to improve the diameter of native coronary artery lesions in patients with symptomatic coronary artery disease. These devices are used where the vessel size matches the scaffold size, and the lesion length is shorter than the scaffold length. Participants will be monitored according to the registry protocols, focusing on outcomes such as Target Lesion Failure over 12 months. The study observes the clinical use and safety of these devices in typical treatment settings without additional restrictions. Patient follow-up and data collection occur throughout the study duration to assess device performance.

This research aims to evaluate the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in treating patients with coronary artery disease who have atherosclerotic lesions between 36 mm and 44 mm in length in native coronary arteries with a vessel diameter of 2.25 mm to 4.0 mm. The study includes patients from the United States and other countries, with different follow-up durations based on location. Patients in the United States are followed for 2 years after the initial procedure, while those outside the United States are followed for 5 years. Participants will receive the Orsiro Mission stent, which is a device combining a cobalt chromium stent platform with a sirolimus drug contained in a bioabsorbable polymer coating. This stent is designed to be placed in the coronary artery to treat the lesion with a single device. The treatment targets one lesion per patient, with certain allowances for additional non-target lesion treatments using other approved methods if needed. Throughout the study, participants will have scheduled follow-up visits to monitor their health and the performance of the stent. In the United States, visits occur at 1, 6, 12, and 24 months after the procedure, while outside the United States, additional visits at 3 and 5 years are included. Researchers will assess the rate of target lesion failure at 12 months and monitor safety and device effectiveness through clinical evaluations and imaging as appropriate.

Researchers are conducting a prospective single-center registry study at the Heart Center in Bad Segeberg, Germany, involving patients with coronary chronic total occlusions. The study aims to follow these patients over time after undergoing treatments to reopen blocked coronary arteries, assessing their cardiovascular health and any adverse events over a long-term period. Patients in this study receive treatment through recanalization of coronary chronic total occlusions using percutaneous transluminal angioplasty with dedicated drug-eluting stents and/or balloons. This approach is part of the revascularization procedure being evaluated, with patients undergoing routine clinical follow-up to monitor their progress and outcomes. Participants will be regularly assessed during scheduled clinical follow-ups, including long-term monitoring to track the rate of cardiovascular adverse events over two years. The study focuses on collecting data related to heart health and any complications following the intervention, helping to understand the safety and outcomes of this treatment approach.

This research aims to follow patients with severe mitral regurgitation (MR) who are treated using mitral transcatheter edge-to-edge repair (M-TEER) at the Heart Center in Bad Segeberg, Germany. It is a prospective single-center registry designed to monitor these patients over time. The goal is to evaluate both the short-term and long-term cardiovascular outcomes after this procedure. Participants receive the mitral valve transcatheter edge-to-edge repair device as the treatment intervention. The study includes patients undergoing this specific procedure for severe MR, with no comparison group mentioned. The registry collects data as patients go through their routine clinical follow-up visits after receiving M-TEER. Patients are followed according to a routine clinical schedule that includes long-term monitoring. Researchers track the rate of cardiovascular adverse events both during the hospital stay and over a two-year period afterward. This follow-up helps to understand health outcomes and safety related to the procedure, with total participation lasting at least two years.

This research focuses on patients with coronary artery disease who are undergoing rotational atherectomy, a procedure used to treat coronary lesions. It is a prospective, single-center study conducted at the Heart Center in Bad Segeberg, Germany, aiming to monitor patient outcomes over time through routine clinical follow-up and long-term tracking. Participants receive rotational atherectomy for their coronary lesions as part of their treatment. The study does not involve comparison groups or different interventions but observes all patients treated with this procedure at the center. During the study, patients follow a standard clinical schedule that includes both immediate and long-term follow-up visits. Researchers measure the rate of in-hospital and long-term cardiovascular adverse events over a two-year period to assess patient safety and outcomes after the procedure.