Arlon

Researchers are evaluating the safety and performance of remote monitoring functions in pacemakers, specifically the ALIZEA, BOREA, and CELEA devices. These remote features include the Right Atrial Autothreshold (RAAT), Right Ventricular Autothreshold (RVAT), and technical remote alerts. The study focuses on patients with bradycardia who have recently received one of these pacemakers as part of their cardiac care. Participants will undergo implantation or device upgrade with an ALIZEA, BOREA, or CELEA dual chamber pacemaker. The study involves activating remote monitoring functions on these devices to track cardiac pacing performance and system safety. Follow-up visits will occur at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion, during which device function and remote monitoring data will be assessed. During each follow-up, either in person or remotely, researchers will measure the pacemaker's performance, including pacing thresholds and remote alerts. Safety will be closely monitored throughout the entire 48-month study period. The main outcomes include changes in right atrial and right ventricular pacing thresholds and documentation of technical remote alerts between 1 and 3 months after device implantation.

Researchers are studying coronary catheterization procedures to compare distal radial access (DRA) with conventional transradial access (TRA). The trial aims to evaluate whether using advanced hemostasis techniques and ultrasound-guided puncture can improve the safety and effectiveness of DRA, which has shown a lower risk of radial artery occlusion and fewer vascular complications but also a lower success rate compared to conventional TRA. This dual randomized pragmatic trial addresses gaps in knowledge about the duration of hemostasis and success rates with DRA. The study involves using potassium ferrate hemostatic patches to enhance hemostasis in both distal radial and conventional transradial access. It also compares ultrasound guidance versus conventional guidance for puncture during distal radial access. These interventions are tested to see if they can shorten hemostasis time and increase procedural success. The study includes two main procedural approaches with different devices and guidance methods to determine their effectiveness. Participants are adults aged 18 years or older who need coronary angiography or percutaneous coronary intervention and have a palpable radial pulse at both conventional and distal puncture sites. They will be monitored for outcomes such as hemostasis duration and access success, with timing recorded from anesthesia needle contact to sheath placement and from procedure end to hemostasis completion. Safety and protocol adherence are also assessed, with informed consent and compliance required throughout the study.

Researchers are evaluating the use of a 7F distal radial artery (DRA) access compared to the conventional 7F transradial artery (TRA) access for complex large-bore percutaneous coronary interventions (PCI). Complex coronary lesions include chronic total occlusions, left main coronary artery disease, heavily calcified lesions, and complex bifurcations. Although the radial artery is the standard access for most PCIs, its small size limits the use of large bore catheters. The study builds on previous findings that showed DRA to be a promising alternative to reduce radial artery occlusion (RAO) and seeks to compare the feasibility and safety of 7F DRA versus 7F TRA for these complex cases. Participants will undergo PCI using a 7F GLIDESHEATH SLENDER® radial sheath, designed with a thinner wall and hydrophilic coating to accommodate large bore catheters with a smaller outer diameter. The study compares large-bore radial access via either distal radial artery or conventional transradial artery routes. The intervention involves complex PCI with the Ultimaster family drug-eluting stent. The trial is prospective, multicenter, and randomized, involving patients who require 7F guiding catheters for complex coronary lesion treatment. During the study, participants will be assessed for radial artery occlusion at hospital discharge (up to 5 days). Clinical assessments and Doppler ultrasound imaging will be used to monitor vascular access-site complications. Researchers will measure procedural success rates, incidence of RAO, and safety outcomes. The trial excludes patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, chronic hemodialysis, or contraindications to transradial access. Total participation duration includes the PCI procedure and follow-up assessment at discharge.

Human papillomavirus (HPV) infection is very common and often causes warts in people of all ages. This study evaluates the effectiveness of 2LVERU4 JUNIOR and 2LVERU4 treatments compared to a placebo in helping warts disappear. The trial aims to compare how well these treatments work by the end of a 6-month period, focusing on common, flat, and plantar warts caused by HPV. It is a phase 4, randomized, placebo-controlled, double-blind study involving patients aged 3 years and older. Participants will be assigned to one of two groups: one receiving 2LVERU4 JUNIOR or 2LVERU4 capsules, and the other receiving placebo capsules. Each participant will take one capsule daily, 15 to 30 minutes before breakfast on an empty stomach, following a sequence of capsules numbered 1 through 10, repeated continuously for 6 months. After the treatment phase, there is a 3-month follow-up period to monitor results and any possible recurrence of warts. During the study, patients will be monitored for wart disappearance, defined by normal skin color, texture, and touch at the wart site. Assessments will take place at 4 and 6 months after starting treatment, with additional evaluation of wart recurrence 3 months after treatment ends. Researchers will also compare pain levels related to warts and monitor safety throughout the study. The total study duration can last up to 45 months, including 36 months for patient enrollment and 9 months for follow-up.