Catheter

This research aims to gather detailed, high-quality data on the performance, safety, and clinical benefits of Teleflexs vascular access devices when used in everyday medical settings. The study focuses on a range of devices including central venous access devices, midline catheters, peripheral catheters, hemodialysis catheters, arterial catheters, and tip confirmation devices, many with antimicrobial and antithrombogenic features. Participants will undergo procedures involving these Teleflex devices as needed for therapy or diagnosis. The registry tracks the use of these devices along with related accessories used for placement and maintenance, collecting data on their safety and effectiveness in real-world practice. During the study, participants device use will be monitored, including successful device use without removal due to device-related events and verification of catheter tip location. Safety is assessed through monitoring device-related adverse events within 7 days after device removal. The study runs from December 2024 to December 2034, involving data collection during and shortly after device use.

Bladder cancer is a common type of cancer, especially in men, and most cases are non-muscle invasive at diagnosis. When it progresses to muscle-invasive bladder cancer, treatment usually involves chemotherapy followed by surgery called radical cystectomy with urinary diversion. Despite surgical advances, complications after this surgery remain frequent. The role and timing of ureteric stenting during this surgery to prevent urinary leakage and obstruction is uncertain, and prior studies have shown mixed results regarding its benefits and risks. This study is a randomized trial comparing early versus late removal of ureteral JJ stents after radical cystectomy and ileal conduit formation. Participants will be assigned to either have their stents removed early, between 5 and 7 days after surgery, or late, between 4 and 6 weeks after surgery. The study aims to assess the feasibility of conducting a larger definitive trial by evaluating complication rates and other outcomes related to the timing of stent removal. Participants will be monitored for complications within 30 days, 90 days, and up to one year after surgery. The study will also track readmission rates and feasibility outcomes over one year. Researchers will collect data on surgical complications and recovery, with no blinding involved. The total duration of participation varies, with follow-up visits to assess the effects of early versus late stent removal on patient outcomes.

Researchers are developing and validating a multimodal artificial intelligence AI model to predict treatment-related complications in children with perimembranous ventricular septal defect pmVSD who undergo transcatheter device closure. This observational study aims to determine if integrating data such as demographics, lab results, electronic health records, echocardiography reports, chest X-rays, and electrocardiograms can help accurately assess individual risk of complications within 30 days after the procedure. The study collects data retrospectively from routine clinical care records of pediatric patients who had the transcatheter closure for pmVSD. Deep learning techniques will be applied to extract features from text and imaging to train and validate the AI prediction model. No direct treatment or intervention is administered as part of this study. Participants involvement consists of the use of their existing medical records and clinical data. Researchers will analyze this information to measure procedure-related complications up to 30 days following closure, and evaluate the models accuracy through metrics like sensitivity, positive and negative predictive values, and precision-recall curves. The study is expected to be completed by the end of 2027.

Researchers are evaluating the Methinks Stroke Suite, an AI-based imaging software, to see if it can help speed up the transfer of acute stroke patients who may need thrombectomy from local stroke centers to specialized centers. The study focuses on patients initially assessed at centers that cannot perform endovascular therapy EVT. The main goals are to find out whether the software reduces the time to decide on patient transfer and how accurately it identifies candidates for EVT. The study compares patient care after integrating Methinks Stroke Suite into the stroke workflow with a historical group treated before its use. Patients will have a CT scan analyzed by the AI software at the local center. If the software and clinical judgment suggest thrombectomy might be needed, patients are transferred to specialized centers. If no large vessel occlusion is detected, further imaging like CT angiography may be done to reassess. This is an open-label, quasi-experimental study conducted across multiple centers in Catalonia, Spain. Participants will undergo CT scans at their local stroke center, with imaging data processed by the Methinks software. They will be followed for 90 days after their stroke to assess recovery and functional outcomes. Researchers will measure time from arrival to transfer decision, evaluate the softwares accuracy in detecting large vessel occlusions, monitor treatment rates, and gather clinician feedback on using the software. Safety during patient transfers will also be tracked. The study plans to enroll about 250 patients and includes a follow-up period of 3 months after stroke.

This research aims to observe and evaluate the outcomes of endovascular treatment for acute ischemic stroke AIS caused by vessel blockage in the brains anterior or posterior circulation. The study is a prospective, multicenter, observational trial designed to assess the safety and functional recovery of patients receiving this treatment in routine clinical settings. Participants receive endovascular treatment, which may include mechanical thrombectomy using devices such as stents, aspiration catheters, or combinations with intra-arterial clot-dissolving therapies. The study records these procedures as part of standard care without randomization or comparison groups since it is observational. During the study, researchers will track patients recovery and safety outcomes through various assessments, including a primary focus on functional improvement measured by the modified Rankin scale at 90 days. Additional measures include neurological status at 24 hours and 7 days, as well as details about blood vessel reopening immediately after and during the procedure. The study intends to provide insights into real-world treatment results and safety over the follow-up period.

Researchers are evaluating two types of devices used to secure urinary catheters in critically ill patients adhesive devices and elastic wristband-style devices. The study aims to determine which device is more effective at preventing injuries to the urethral meatus, reducing patient discomfort, and lowering the rate of catheter-associated urinary tract infections. This is an experimental, randomized trial conducted in an Intensive Care Unit setting, addressing a significant gap in clinical guidelines and nursing practices regarding catheter securement methods. Participants will be randomly assigned to use either a commercially available adhesive device or an elastic wristband device to secure their urinary catheter on the front of the thigh. The placement is carefully chosen to allow leg movement without tension on the catheter. For adhesive devices, a protective barrier spray is applied before use, while elastic bands are adjusted to minimize movement and maintain circulation. Devices will be replaced every 72 hours or earlier if needed, alternating the thigh used for securement at each change. During the study, participants will be regularly monitored for catheter-related complications such as meatal injuries, discomfort or pain if the patient can communicate, and urinary tract infections. Researchers will collect feedback from communicative patients about their comfort and any issues experienced. The primary outcomes are measured over an average period of 10 days. This monitoring includes clinical assessments and tracking any adverse events like catheter obstruction, skin lesions, or accidental catheter dislodgement.

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation PVI using high power short duration HPSD radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation AF. This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedures overall safety and efficacy.

This research aims to evaluate how well an autonomous blood drawing device works and whether it is safe. The study includes several phases, with Phase B1 being a key clinical trial to confirm that the device performs at least as well as manual blood drawing, which is important for regulatory approval. Earlier and later phases focus on improving the technology and usability, including testing non-invasive features like ultrasound detection. Participants will receive blood draws using the Venipuncture Device, which fully automates the procedure by detecting veins with near-infrared and ultrasound imaging, inserting a needle robotically, connecting blood tubes, and applying pressure to the puncture site. Depending on the phase, the device may replace or supplement manual blood draws. Some phases involve one or two automated draws, and the technology is progressively improved, with more manual steps required in early phases and fewer later on. During the study, participants will undergo standard blood drawing procedures at outpatient blood drawing departments or at a volunteer site. Researchers will measure the success rate of first-time venipuncture, the rate of punctured participants, hemolyzed samples, and adverse events over seven days. The study includes safety monitoring, and participant involvement varies by phase, with some receiving additional automated blood draws beyond routine care.

Atrial fibrillation AF is a common heart rhythm disorder that greatly increases the risk of stroke, heart failure, hospitalization, and death. This research aims to compare two treatment approaches for elderly AF patients who are frail and have a high risk of bleeding. The study evaluates catheter ablation combined with left atrial appendage occlusion LAAO against catheter ablation combined with long-term oral anticoagulation OAC, addressing a current gap in evidence about the best strategy for this vulnerable group. Participants will be randomly assigned to one of two groups one receiving catheter ablation plus LAAO, a device-based procedure to prevent stroke, and the other receiving catheter ablation plus standard oral anticoagulation therapy. The LAAO procedure may be done during the ablation session or separately. After LAAO, participants receive anticoagulation for 90 days, followed by possible de-escalation based on imaging results. The other group continues guideline-directed anticoagulation after ablation. Both groups are closely monitored for safety and effectiveness. During the 24-month study, participants will undergo regular assessments including ECGs, Holter monitoring to track heart rhythm, and imaging tests to evaluate heart function and device status. Researchers will measure outcomes such as stroke, bleeding events, death, AF recurrence, and quality of life. Additional evaluations include frailty scores, cognitive function, and daily living activities. The study also monitors procedural success, hospital stay length, and complications to help determine which treatment better supports elderly patients with AF.

This research aims to evaluate the immediate effectiveness and durability of the cavo-tricuspid isthmus CTI block using pulsed electric field PEF energy in patients with atrial fibrillation AF and typical atrial flutter. The study will also determine the best waiting time to detect recovery of conduction after PEF CTI ablation and assess the usefulness of routine adenosine testing for dormant conduction. Additionally, it compares two catheter configurations, basket and flower, to study differences in acute success and side effects like hemolysis and coronary vasospasm. Participants undergo catheter ablation of the CTI using either the flower or basket configuration of the Farapulse catheter in a randomized 11 assignment. Ablations are performed during atrial pacing under anesthesia with intracardiac echocardiography guidance. Patients receive sublingual nitrates before ablation, and sequential PEF applications are delivered until CTI block is achieved. Adenosine testing for dormant conduction and monitoring of conduction recovery times are performed during the procedure. Blood samples to measure plasma biomarkers are collected before and after CTI isolation. Throughout the study, patients are monitored using catheters in the heart, electrocardiograms, and intracardiac imaging. Researchers measure the acute durability of the CTI block, time to conduction recovery, presence of dormant conduction via adenosine testing, plasma hemoglobin levels, and coronary vasospasm occurrence. The study includes 150 patients aged 18 and older, with follow-up during the ablation procedure to assess these outcomes under continuous observation. The total participation time corresponds to the duration of the ablation procedure and associated assessments.