Massy

This research aims to observe patients who participated in the EXCELLENT clinical trial for acute myocardial infarction. It focuses on comparing long-term clinical outcomes between those who received standard care and those treated with ProtheraCytes. The study is designed to follow these patients for up to 10 years to gather valuable safety and efficacy data. Participants include those from both the standard of care group and the ProtheraCytes treatment group who have completed their 6-month follow-up in the original EXCELLENT trial. This observational study involves collecting data without additional interventions or treatments. The study duration spans an average of 10 years from the initial randomization in the EXCELLENT trial. During the study, researchers will monitor participants regularly to assess safety and treatment outcomes over the long term. Data collection includes clinical evaluations and tracking of any health changes. The study does not involve new treatments but focuses on observing and comparing patient progress. Participants will continue their usual care outside the study, and their safety will be monitored throughout.

Researchers are evaluating the safety and effectiveness of radiofrequency RF ablation treatment for type I atrial flutter using the Vision-MR Ablation Catheter 2.0 in an interventional cardiac magnetic resonance iCMR environment. This prospective, single-arm, multi-center clinical trial aims to gather data on how well this device works and how safe it is for patients with this heart rhythm disorder. The study involves performing type I atrial flutter ablation using the Vision-MR Ablation Catheter 2.0 together with the Advantage-MR EP recorder and stimulator system within the iCMR setting. Participants will receive this treatment during the procedure, which is guided by magnetic resonance imaging to target the affected heart area precisely. Participants will be monitored during and after the procedure to confirm successful blockage of arrhythmia pathways and to track any serious cardiovascular adverse events up to 7 days post-procedure. Further follow-up at 90 days will evaluate the continued absence of atrial flutter episodes and monitor for any serious adverse events throughout the study duration. The trial will assess these clinical outcomes to understand the efficacy and safety of the RF ablation device.

Researchers are evaluating the Colibri Transcatheter Aortic Heart Valve System in patients aged over 75 years who have symptomatic severe aortic stenosis and are at high surgical risk. This prospective, single-arm clinical investigation will be conducted at about seven European sites to assess the safety and performance of this heart valve system compared to recent historical results. The primary focus is on the rate of all-cause mortality at 30 days post-implantation, with additional evaluations up to five years after the procedure. Participants will receive the Colibri heart valve implanted via transfemoral access. This treatment is intended for patients with severe aortic tricuspid valve stenosis who meet specific anatomical and clinical criteria, such as heart valve measurements and surgical risk assessments. The study involves a single treatment group receiving the investigational device, with follow-up visits scheduled at 30 days, 6 months, 12 months, and annually up to five years to monitor the devices performance and safety. During the study, participants will undergo assessments including ECG-gated Multi-Slice Computed Tomography MSCT for valve measurements and clinical evaluations by the Heart Team and a Centralized Case Review Committee. Researchers will track mortality and adverse events, along with heart function and symptom status. Participants are expected to provide informed consent and agree to scheduled follow-ups to help researchers understand the devices long-term impact on patient health and safety.

Researchers are studying adults who have experienced cardiac arrest and are admitted to intensive care while comatose. The study focuses on comparing different early brain damage scoring systems to identify which best predicts patient outcomes. This research aims to help doctors decide the best post-resuscitation treatments and provide accurate information to families. The sponsor of the study is AfterROSC. The study observes patients without assigning treatments. At intensive care unit admission, usually about 3 hours after cardiac arrest, researchers calculate early prognosis scores based on clinical and biological data. This scoring is done for all eligible patients without altering their care. The main focus is to evaluate the performance of the Cerebral Admission Hospital Prognosis CAHP score. Participants will be monitored starting from intensive care admission, with data collected on their condition and brain damage scores. Researchers use these scores to assess outcomes and compare scoring systems. The study does not specify treatment changes, focusing instead on diagnostic evaluation and prognosis. Participation involves no additional interventions beyond standard care and clinical data collection.

Researchers are evaluating a new method to record the hearts electrical activity using a high-density electrocardiogram HD ECG with 128 electrodes placed on the body surface. This method aims to capture more detailed cardiac signals compared to the conventional 12-lead ECG, which measures electrical activity from fewer locations and may miss signals from certain areas. The study focuses on patients with ventricular arrhythmias or related heart conditions to see if HD ECG provides additional clinical information. The study involves two types of ECG recordings done simultaneously the standard 12-lead ECG and the experimental HD ECG device. The HD ECG uses 128 skin electrodes arranged in strips, prepared with adhesive tape and conductive gel, recording for 10 to 30 minutes. The conventional 12-lead ECG is derived from specific electrodes within the HD ECG setup, plus four limb electrodes for frontal leads. Participants include those with documented or suspected severe ventricular arrhythmias or those undergoing preventive ventricular defibrillator implantation. Participants will undergo both ECG recordings on the same day, during which researchers will identify electrical criteria such as amplitude, timing, duration, and anatomical locations of cardiac activity using the HD ECG. The study measures these outcomes to assess the sensitivity of the HD ECG method. The trial is non-blinded and conducted at Bordeaux University Hospital, with patient safety monitored throughout the recording process. The total participation involves one study visit for the ECG assessments.

This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.

Researchers are evaluating the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients who have moderate to severe mitral regurgitation and are considered high risk for traditional open-heart surgery. This study focuses on patients with significant mitral valve leakage and who have specific heart failure symptoms classified as New York Heart Association NYHA Class II, III, or ambulatory IV. The study is sponsored by HighLife SAS and aims to gather information on this device in a real-world setting without randomization. Participants will receive the HighLife Transcatheter Mitral Valve Replacement device through a trans-septal catheter procedure. This is a single-arm, non-randomized study where all participants undergo this intervention. The study will monitor the devices safety primarily within the first 30 days after implantation. The procedure is designed for patients who meet specific anatomical criteria and have been on guideline-directed medical therapy for at least one month. Throughout the study, participants will be closely followed with scheduled assessments to evaluate the devices safety and overall performance. Researchers will monitor for adverse events and clinical outcomes, focusing on the 30-day safety period after treatment. The study includes follow-up visits and evaluations to ensure participant well-being and to gather comprehensive data on the devices effects. Participation lasts according to the study protocol, with ongoing monitoring as needed.

Researchers are evaluating the use of arginine-vasopressin AVP and hydrocortisone compared with norepinephrine to improve survival and neurological recovery 30 days after cardiac arrest in patients experiencing hemodynamic failure. This phase 3, multicenter trial focuses on patients who have been successfully resuscitated but face post-resuscitation syndrome, which includes multiple organ failures and brain damage caused by a combination of heart and circulatory problems often linked to hormonal imbalances. The study randomly assigns participants to one of four groups AVP with placebo hydrocortisone, placebo AVP with hydrocortisone, both AVP and hydrocortisone, or placebo for both. AVP is given via infusion to maintain a target blood pressure for up to 3 days, while hydrocortisone is administered intravenously every 6 hours for 7 days without tapering at the end. Placebo treatments are used to compare effects. The trial involves 17 intensive care units in France and aims to enroll 380 patients. Participants will be closely monitored throughout the study with assessments including neurological outcome measured at day 30, along with various mortality causes and brain damage evaluations at 48 and 72 hours. Researchers will track survival, brain function recovery, and hemodynamic stability during and after treatment. The study uses quadruple masking to ensure unbiased results and includes ongoing safety and follow-up evaluations until December 2025.

Researchers are evaluating the impact of adding three sensory elementsvisual, auditory, and olfactoryto help reduce discomfort in adult patients hospitalized in intensive care or continuing care units. This study includes patients admitted for medical or surgical reasons, whether conscious or unconscious and under mechanical ventilation. The goal is to explore supportive care methods to improve patient comfort during hospital stays. Participants are randomly assigned to either an experimental group that experiences an immersive sensory environment in their hospital room or a control group that receives standard care without sensory projections. The sensory environment includes light frescoes themed on nature with a circadian cycle, immersive nature sounds that are non-repetitive, and the use of essential oils. All patients continue to receive usual medical care and support from the hospital team. Throughout the study, patients and their relatives will be monitored and supported as per usual intensive care practices. Researchers will assess patient discomfort using the REAnimation Patient Discomfort Questionnaire over a two-month period. The study involves informed consent from patients or their trusted persons who understand French and the research procedures. The total participation timeline aligns with the hospitalization duration and follow-up for assessing discomfort.

Researchers are comparing the safety and effectiveness of the Myval Transcatheter Heart Valve THV Series with other contemporary valve devices, specifically the Sapien THV Series and Evolut THV Series, in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational trial aims to determine if the Myval THV Series performs at least as well as these established valves for treating this condition. The study will enroll a total of 768 participants, with equal numbers receiving either the Myval THV or the contemporary valves. Participants will receive heart valve replacements via the transfemoral approach using valves sized appropriately for their anatomy. The Myval THV Series includes several device sizes ranging from 20 mm to 29 mm, while the comparator devices include Sapien and Evolut valves in various sizes. The trial also features a non-randomized nested registry to evaluate extra-large Myval valves 30.5 mm and 32 mm and a lead-in phase where investigators perform initial implantations to ensure protocol adherence before enrolling study subjects. Throughout the study, participants will be closely monitored with assessments of valve safety and effectiveness using criteria defined by the Valve Academic Research Consortium-3 VARC-3. Outcomes measured include mortality, stroke, kidney injury, bleeding, valve function, device success, and quality of life, among others, followed up to 10 years. The study includes detailed safety and efficacy evaluations at multiple time points, including pre-discharge, 30 days, 1 year, and longer-term follow-ups. Participants will undergo clinical evaluations, echocardiography, and quality of life questionnaires during these visits.