Bad Segeberg

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 focuses on patients who have experienced ST segment elevation myocardial infarction STEMI and require percutaneous coronary intervention PCI. The study compares two approaches a shorter duration of dual antiplatelet therapy DAPT with Prasugrel followed by Prasugrel monotherapy versus the standard one-year DAPT regimen. Additionally, in patients with multivessel disease MVD, the trial evaluates the effectiveness and safety of complete revascularization guided by either Optical Coherence Tomography OCT or angiography. Participants receive a loading dose of aspirin and Prasugrel at the time of PCI, treating the culprit lesion first. For those with MVD, non-culprit lesions are treated in staged procedures within 15 days. Following 30 to 45 days after the initial procedure, eligible patients are randomized to either continue short DAPT with Prasugrel monotherapy or follow the standard 12-month DAPT. Complete revascularization in MVD patients is further randomized to OCT-guided or angiography-guided strategies. Participants will be followed clinically for 35 months after randomization to monitor outcomes, with key assessments at 11 and 35 months. Researchers will measure safety and efficacy endpoints, including major adverse cardiac and cerebrovascular events and bleeding events. The study includes detailed monitoring of treatment adherence, successful revascularization, and clinical events to evaluate the comparative benefits of the treatment strategies.

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.

Researchers are evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.

Researchers are monitoring the clinical performance and short-term safety of Resorbable Magnesium Scaffolds RMS used in patients with symptomatic coronary artery disease. This registry follows the ESCEACTS guideline and observes RMS use in real-world settings without additional medical exclusion criteria beyond the devices intended instructions for use. The devices studied include Magmaris and Freesolve, both designed to improve the luminal diameter in the treatment of new native coronary artery lesions. The scaffold size is matched to the vessel diameter, and lesion length is limited to the scaffold length. The study collects data on these devices as they are used according to their approved instructions. Participants will be followed to assess the primary outcome of Target Lesion Failure within 12 months after device implantation. The registry collects clinical information during routine care to evaluate device performance and safety over time. The study started in November 2020 and will continue through May 2030.

Researchers are evaluating the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with coronary artery disease who have atherosclerotic lesions longer than 36 mm and up to 44 mm in their native coronary arteries. The study focuses on lesions with a reference vessel diameter between 2.25 mm and 4.0 mm. This is a prospective, multicenter, single-arm study sponsored by Teleflex, aiming to treat subjects with these specific lesions using this device. Participants will receive the Orsiro Mission stent, which consists of a cobalt chromium stent platform coated with a bioabsorbable polymer containing the drug sirolimus. This device is designed to be implanted in the coronary arteries during percutaneous coronary intervention PCI. The study involves a single group receiving this stent to assess its performance in treating lesions of the specified length and size. During the study, participants will have follow-up visits to monitor outcomes and safety. Those enrolled in the United States will be followed for 2 years with visits at 1, 6, 12 months, and 2 years after the procedure. Participants outside the United States will be followed for 5 years with additional visits at 3 and 5 years. Researchers will measure target lesion failure at 12 months as the primary outcome and will also track device and procedure success, deaths, heart attacks, major cardiac events, revascularizations, and stent thrombosis throughout the follow-up period.

This research focuses on patients with coronary chronic total occlusions undergoing recanalization procedures. It is a prospective registry conducted at the Heart Center in Bad Segeberg, Germany, tracking patients treated for these heart artery blockages. The study aims to observe outcomes over time, including complications and cardiovascular events. Participants undergo percutaneous transluminal angioplasty using dedicated drug-eluting stents andor balloons as part of their treatment for coronary chronic total occlusions. The registry records details of these procedures and the patients receiving them, without randomization or comparison groups. The study collects data throughout routine clinical care and follow-up visits. During the study, patients will be monitored for in-hospital and long-term cardiovascular adverse events, with follow-up extending up to at least two years. The study involves regular clinical assessments and data collection to evaluate the safety and outcomes of the recanalization procedures. Participation continues with standard medical care and long-term observation at the center.

This research aims to follow patients with severe mitral regurgitation MR who are treated using a procedure called mitral edge-to-edge repair M-TEER. The study is conducted at a single center, the Heart Center in Bad Segeberg, Germany, and focuses on observing patients undergoing this treatment to understand their health outcomes over time. Participants receive the mitral valve transcatheter edge-to-edge repair M-TEER, a device-based procedure designed to address severe MR. The study records data from patients treated with this procedure and follows them through a routine clinical schedule, including long-term follow-up to monitor their condition and treatment effects. Throughout the study, participants undergo regular clinical assessments, with researchers tracking their health status and any cardiovascular adverse events that occur both during hospitalization and over a two-year period. The main outcome measured is the rate of these adverse events. Participants are monitored closely according to the study protocol, which extends over a long-term timeline to gather comprehensive follow-up information.

This observational study follows patients with coronary artery disease who undergo rotational atherectomy for coronary lesions at the Heart Center in Bad Segeberg, Germany. It aims to collect long-term data on cardiovascular outcomes after this procedure as part of routine clinical care, providing insights into patient experiences and health over time. Patients receive rotational atherectomy as part of their coronary artery disease treatment. The study includes all patients undergoing this procedure and follows them with a routine clinical follow-up schedule. The study is conducted at a single center and involves no experimental treatment or placebo. Participants are monitored through standard clinical visits over a long-term period, with researchers tracking the rate of in-hospital and long-term cardiovascular adverse events within two years. This data will help evaluate the safety and outcomes of rotational atherectomy in everyday clinical practice. The total participation time varies based on the follow-up schedule.

This research focuses on patients with aortic valve stenosis who receive transcatheter aortic valve implantation TAVI at the Heart Center in Bad Segeberg, Germany. It is a prospective, single-center registry study aimed at collecting long-term data on these patients to better understand valve durability and patient outcomes over time. Participants undergo TAVI, which involves an interventional replacement of the aortic valve using a device. After the procedure, patients follow a routine clinical and echocardiographic follow-up schedule, including long-term monitoring beyond five years to assess the condition of the implanted valve. Throughout the study, participants will have regular clinical evaluations and heart ultrasounds to track their health and valve performance. Researchers will measure outcomes such as mortality up to 10 years after treatment and any structural deterioration of the valve. The study began in September 2007 and plans to continue through December 2032, providing extensive long-term data.