Bad Neustadt An Der Saale, Germany

GLYCAR Post Market Multicenter Study

This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enroll up to 100 consecutive subjects undergoing cardiac and/or vascular repair or reconstruction surgery in 10-12 investigative sites in the European Union (EU), South Africa and USA. The study is aimed at providing real-world evidence of the Glycar Pericardial patch device performance and incidence of clinical outcomes in patients undergoing cardiac and/or vascular repair or reconstruction surgery related to Glycar Pericardial patch.

Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

Pulmonary Vein Isolation Vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients with AF

Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Atrial fibrillation is commonly induced and maintained by abnormal electrical impulses originating in the pulmonary veins. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. This is achieved either by heating (Radiofrequency ablation) or freezing (Cryoablation) of the tissues. By inducing the formation of scar tissue, the pulmonary veins are "electrically isolated" and abnormal electrical signals are not transferred any more to the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. The effect was shown to be significantly higher compared with conventional medical treatment. In contrast, there is no evidence for a substantial effect of PVI on hard clinical endpoints. The recent large randomized controlled trial CABANA (Catheter ABlation vs. ANtiarrhythmic Drug Therapy for Atrial Fibrillation) did not show a reduction of the primary composite endpoint of death, disabling stroke, serious bleeding and cardiac arrest in the intention-to-treat analysis although the results are highly controversial due to the high crossover rate. Up to now, the only patient population with evidence for a prognostic benefit of PVI in symptomatic AF are patients with a heart failure and a reduced ejection fraction (HFrEF). In the CASTLE-AF trial, a relative risk reduction for all-cause mortality of 47% was shown for HFrEF patients with AF ablation compared with conventional treatment. 7-Day Holter monitoring in patients 6 month after treatment with PVI revealed a significant increase in asymptomatic AF episodes. Furthermore, the MANTRA-PAF randomised trial (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. This raises concerns that the symptomatic improvement might be the result of a placebo effect. PVI-SHAM-AF is a prospective, double-blinded, sham-controlled, randomized, multicenter trial whose aim is to compare the effect of catheter-based ablation on patient reported outcomes based on common AF questionnaires with a sham procedure. 260 patients without previous PVI or surgical treatment of atrial fibrillation, a LVEF >35% and an indication for interventional treatment of AF with pulmonary vein isolation based on current Guidelines (ESC 2020) will be enrolled and randomized 2:1 to undergo either PVI or sham procedure. The latter will include deep sedation as performed during standard PVI treatment for at least one hour, introduction of femoral sheaths and if necessary electrical cardioversion in patients with persisting AF. No catheter will be placed within the participant. The official procedure protocol will include no details about the intervention; postinterventional care will be conducted independent of whether a catheter ablation or sham procedure was performed, based on the respective PVI protocol. Patient will be followed up for one year with visit at 3, 6 and 12 months. Each of these visits include questionnaires for AF related Symptoms (AFEQT, SF-36 and EQ-5D); 7-Day Holter Monitoring will be performed 6 months after the procedure. Participants will be unblinded after 12 months. The primary endpoint will be the difference of AFEQT sum scores evaluated at 6 months to baseline.

Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis

Prospective, single center, open-label study to 1. compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI 2. correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI 3. correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.

Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery. Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement. RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography. Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.

Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease. The course of the disease is characterized by a slow destruction of bile ducts, and progressive cholestasis. Prognosis depends on the development of cirrhosis and its complications. Ursodeoxycholic acid (UDCA) has been established as standard therapy for PBC and improves patients' long-term outcome. However, UDCA is not a uniformly effective drug, and the prognosis of PBC patients insufficiently responding to treatment is markedly worse. For patients with suboptimal treatment response to UDCA obeticholic acid (OCA) as newly approved medication (OCALIVA®) is available as second line treatment. Due to the low prevalence and the slowly progressive course of the disease it is very difficult to investigate the prognosis of subgroups of PBC patients or to evaluate the effectivness of therapeutic interventions on clinical outcomes. Therefore, several national or international registries (UK-PBC Consortium or the Global PBC Study Group) were founded to better characterize the clinical course of PBC patients. Since in Germany a registry for PBC does not exist, the German PBC Cohort is being implemented as observational study to collect data on treatment progress and success in clinical routine that reflects real world conditions in Germany as closely as possible. The effectiveness and safety/tolerability of PBC treatment options (UDCA as standard therapy and second-line treatment options like OCALIVA in case of inadequate UDCA treatment response) will be evaluated. In approximatly 40 sites in Germany routine data is collected. There are no specifications for the diagnosis, therapy and monitoring of the PBC patients. The documentation of the routine data is carried out alongside with guideline recommended treatment intervals of the patients. Furthermore, a critical criterion for the German PBC Cohort study is the involvement of a sufficient number of gastroenterology specialized practices and outpatient clinics that have consciously not been selected based on the strict specifications of a clinical trial and which provide routine treatment for PBC patients. In addition, patient access is designed to be open. Data will be collected on patient groups that represent a majority of the PBC patients in Germany, but who are not being investigated in clinical trials.

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects with Peripheral Arterial Disease

Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled: The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.

Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom require mandibular reconstruction. The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection. Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants. Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.