Ingolstadt

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 the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other procedures like cutting or super high pressure balloon angioplasty and ablative methods in treating severely calcified coronary artery lesions. The study focuses on patients with coronary artery disease who have severe calcification in their coronary arteries, aiming to improve the preparation and treatment of these blockages. This is a randomized, multicenter clinical trial assessing these different methods to better understand their benefits in lesion treatment. Participants receive either intravascular lithotripsy (IVL) using balloons with a burst pressure of up to 18 atmospheres or standard non-IVL methods such as special high pressure, super high pressure, cutting balloons, and ablative procedures for treating severely calcified lesions. The trial compares these treatment groups to assess additional benefits of coronary lithotripsy. Treatments are performed during the interventional procedure aimed at opening narrowed coronary arteries. During the study, participants are monitored for major cardiac and cerebrovascular events up to 12 months after randomization. Researchers will collect data on the combined endpoint of these serious events to evaluate the treatments' outcomes. Participants must meet specific eligibility criteria and provide informed consent. The study aims to provide insights into the best treatment approaches for patients with severe coronary artery calcification, with follow-up extending over one year after treatment.

Researchers are conducting the REALITY study to collect both short- and long-term safety and effectiveness data on people implanted with Abbott's neurostimulation systems for chronic pain. This prospective, open-label, multi-center study includes a broad range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. Enrollment is planned to be completed within 7 years, with an overall study duration of 13 years including follow-up and close out. Participants will receive market-approved Abbott neurostimulation devices, specifically spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG) systems. Individuals scheduled to receive implantation within 60 days of the baseline visit can join the study. The study does not randomize or compare treatments but monitors the implanted devices over time to gather safety and performance information. During the study, participants will be followed for up to 5 years after implantation with regular assessments to track device- and procedure-related adverse events, deaths, and device deficiencies. These safety outcomes will be measured at multiple time points including baseline, the permanent implant procedure, and every six months up to five years. The study also involves collecting data on patient experience and device performance throughout this period.

Researchers are evaluating the effectiveness of maintenance electroconvulsive therapy (mECT) combined with clozapine treatment in patients with treatment-resistant schizophrenia who have responded to an initial course of ECT. Schizophrenia is a serious mental disorder, and about 15-30% of patients do not respond to standard antipsychotic treatments, including clozapine. This trial aims to determine if mECT can delay relapse and increase the number of relapse-free patients compared to clozapine treatment alone, potentially influencing future treatment guidelines. The study involves two phases: first, an acute ECT series to achieve significant clinical improvement, followed by a randomized, blinded phase where responders receive either clozapine alone or clozapine plus maintenance ECT. The trial plans to enroll 84 patients aged 18 to 75 years who have treatment-resistant schizophrenia. Treatment as usual is compared to the addition of mECT, which is delivered as a device-based therapy. Participants will be monitored over 28 weeks in phase II to measure time to relapse as the primary outcome. Secondary assessments include functioning, quality of life, depression, schizophrenia symptoms, catatonia, stress, self-stigmatization, and cognitive performance. The study includes follow-up visits and data analysis over several years, with the last patient completing a 12-month follow-up phase four years after study start.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.

Parkinson's disease (PD) is a neurological disorder that worsens over time, with symptoms like tremors, stiffness, and slow movement. The speed of progression varies among individuals. This research studies how well foscarbidopa/foslevodopa works for adults in Germany who are at the early advanced stages of Parkinson's disease under normal medical care. Participants will receive foscarbidopa/foslevodopa through a subcutaneous infusion as prescribed by their doctors. Around 125 adult participants will be enrolled across about 20 sites in Germany. The study follows participants for up to 12 months with no expected extra burden beyond usual clinical visits. During the study, participants will attend routine hospital or clinic visits as part of their regular care. Researchers will measure changes in the time participants experience "OFF" periods, when symptoms return, over up to 12 months. This will help assess the drug's real-world effectiveness on motor symptoms, quality of life, psychosocial functioning, and work ability.