Ingolstadt

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 evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other lesion preparation methods like cutting or super high pressure balloon angioplasty and ablative procedures. The study focuses on treatment of severely calcified coronary artery stenoses in patients with coronary artery disease. It is a randomized, double-blind trial sponsored by Deutsches Herzzentrum Muenchen. Participants receive lesion preparation either by intravascular lithotripsy using balloons with a rated burst pressure of up to 18 atm or by other standard methods such as high, super high, cutting balloons, and ablative techniques. These procedures are performed before intracoronary stenting. The trial compares these approaches to assess additional benefits in treating severely calcified coronary lesions. During the study, participants are monitored for major cardiac and cerebrovascular events over 12 months after randomization. Researchers also track mortality, myocardial infarction, stroke, need for vessel revascularization, stent thrombosis, hospitalization for acute coronary syndrome, and bleeding events. Symptom assessments for physical and mental health related to coronary heart disease and medical costs are also evaluated. Safety and procedural success are closely observed throughout the study period.

Researchers are investigating the long-term safety and effectiveness of Abbotts neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbotts market-released neurostimulation devices, either spinal cord stimulation SCS or dorsal root ganglion stimulation DRG. Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.

Schizophrenia is a severe mental disorder with significant human and societal costs. Approximately 15-30% of patients do not respond to all known antipsychotic treatments, including clozapine, which is considered the current gold-standard for treatment-resistant cases. This trial aims to evaluate whether adding maintenance electroconvulsive therapy mECT to clozapine treatment improves outcomes for patients who have already responded to an initial course of routine ECT. The goal is to determine if mECT can delay relapse or increase the number of relapse-free patients compared to clozapine treatment alone in clozapine-resistant schizophrenia CRS.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Parkinsons disease is a neurological condition that affects the brain and worsens over time, with symptoms like tremors, stiffness, and slow movement. Researchers are evaluating how effective foscarbidopafoslevodopa is in treating adult German participants who are in the early stages of advanced Parkinsons disease under routine clinical care. This observational study includes about 125 adults prescribed this treatment by their doctors in Germany. Participants will receive foscarbidopafoslevodopa via subcutaneous infusion as their physician prescribes, following local label instructions. The treatment is given during usual clinical visits without extra interventions specifically for the study. Participants will be followed for up to 12 months to monitor their treatment experience and outcomes. During the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will assess changes in OFF time, which refers to periods when Parkinsons symptoms return or worsen, measuring this for up to 12 months. There is no expected additional burden beyond standard care, and participant safety and quality of life will be monitored throughout the study period.