Massy

The PERFECT study is an observational research project that follows patients who were previously randomized in the EXCELLENT clinical trial for acute myocardial infarction. Its purpose is to evaluate the long-term clinical outcomes over an average of 10 years for patients assigned either to the Standard of Care treatment or the ProtheraCytes treatment group. This study aims to provide insight into the safety and effectiveness of these treatments over a decade. As an observational study, it involves no new treatments or interventions but focuses on collecting data from participants who completed the EXCELLENT trial. The study monitors patients from both the ProtheraCytes arm and the Standard of Care arm without altering their previous treatment plans. Participation must occur within 10 years of their initial randomization in the EXCELLENT trial. Participants are involved through ongoing data collection during the study period, with researchers assessing safety and efficacy outcomes up to study completion, around 10 years later. The study includes patients who completed their last visit in the EXCELLENT trial and excludes those who were assigned to the ProtheraCytes group but did not receive the product. Safety and the ability to give informed consent are monitored throughout the study.

The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center trial designed to evaluate the safety and effectiveness of radiofrequency (RF) ablation for treating type I atrial flutter. This study uses the Vision-MR Ablation Catheter 2.0 within an interventional cardiac magnetic resonance (iCMR) environment. The trial focuses on patients with documented episodes of type I atrial flutter and aims to confirm the bi-directional block after ablation while monitoring cardiovascular safety. Participants will undergo RF ablation guided by the Vision-MR Ablation Catheter 2.0 in the iCMR setting. This procedure targets type I atrial flutter and is performed during a single intervention. There are no comparator groups as this is a single-arm study. The primary endpoints include confirmation of bi-directional block immediately after the last ablation energy delivery and monitoring of serious cardiovascular adverse events within seven days post procedure. During the study, participants will be closely monitored for procedure success and safety outcomes. Assessments include confirmation of ablation efficacy at the time of the procedure and safety evaluations for serious cardiovascular events during the week following treatment. The total participation involves the intervention day and the seven-day safety follow-up period. Researchers will collect data to assess both the effectiveness of the ablation and to ensure participant safety.

Researchers are evaluating methods to measure calcifications in native coronary arteries, which are important in heart disease. This non-randomized pilot study compares two imaging techniques: the 3DStent tool using rotational angiography and intracoronary intravascular ultrasound (IVUS). The goal is to assess how well each method quantifies coronary calcifications in patients with calcified coronary lesions. The study uses the 3DStent imaging technique performed with 200° rotational angiography at 30 frames per second while an angioplasty balloon is deflated in the target lesion before or after angioplasty. IVUS imaging is done using an Opticross™ catheter with a slow withdrawal speed and intracoronary nitrate injection. Both imaging methods are applied to the same lesions to compare their measurements. Participants are patients with angiographically calcified coronary lesions who can have the IVUS catheter pass through the lesion. Researchers measure the extent of calcification in degrees using 3DStent and IVUS on the first day of the study. Participants give informed consent and are monitored for safety and data collection. The study includes patients aged 18 and older and involves assessment of coronary lesions using these imaging techniques.

Researchers are evaluating the safety and performance of the Colibri Transcatheter Aortic Heart Valve System in patients with symptomatic severe aortic stenosis who are at high surgical risk. This prospective, multicenter, exploratory clinical investigation will be conducted at about seven European sites. The study focuses on patients with severe aortic tricuspid valve stenosis who meet specific high-risk criteria, including a logistic EuroSCORE I greater than 20% or other risk factors such as frailty and porcelain aorta. The primary goal is to assess the rate of all-cause mortality 30 days after valve implantation, with additional long-term safety and performance evaluations planned up to five years. The investigational treatment involves implanting the Colibri heart valve using a transfemoral access approach. Thirty patients will receive this device. The study does not have a randomized control group but will compare results to recent historical data. Eligibility requires specific measurements of the aortic annulus and confirmation by a centralized committee. The procedure and follow-up visits will be conducted according to a defined schedule to monitor outcomes. Participants will be involved in scheduled follow-ups for up to five years after implantation. Assessments include clinical evaluations, imaging studies, and safety monitoring to track valve performance and patient health. The primary outcome measure is mortality at 30 days post-implantation, while secondary outcomes will assess safety and valve function at intervals of 30 days, 6 months, 12 months, and annually for up to five years. Patients must provide informed consent and agree to comply with the follow-up requirements throughout the study duration.

Researchers are evaluating early brain damage assessment scores in adult patients admitted to intensive care after cardiac arrest. Despite successful return of spontaneous circulation, outcomes remain poor and survival rates vary widely depending on arrest circumstances and post-resuscitation care. The study aims to compare different scoring systems to identify the best way to predict patient outcomes and guide treatment decisions in the critical early period after cardiac arrest. The study involves calculating early prognosis scores at the time of intensive care unit admission using clinical and biological data. These scores will be compared to determine which system most accurately predicts brain damage and patient prognosis following cardiac arrest. Participants will be assessed upon intensive care admission, typically within about three hours after cardiac arrest, using the cerebral admission hospital prognosis (CAHP) score and other scoring models. Data from clinical evaluations and biological tests will be collected to calculate these scores. Researchers will use these measures to determine the area under the curve for each scoring system to evaluate their predictive accuracy for patient outcomes.

This research aims to improve the detection of cardiac electrical activity by comparing a new high-density ECG method with the conventional 12-lead ECG. The study focuses on patients with ventricular arrhythmias or related heart conditions and explores whether using 128 body surface electrodes can provide more detailed information about heart activity than the standard 12 leads. This could help identify electrical patterns associated with severe ventricular arrhythmias or impaired ventricular conduction. Participants will undergo two types of ECG recordings performed at the same time: the experimental high-density ECG using 128 electrodes placed on the body surface and the standard 12-lead ECG using a subset of these electrodes plus limb electrodes. The high-density ECG involves applying strips of electrodes with adhesive tape and conductive gel, with recordings lasting between 10 to 30 minutes. This simultaneous recording allows comparison of electrical signals captured by both methods. During the study visit, researchers will measure various electrical criteria from the high-density ECG, including amplitude, cardiac timing, duration, and anatomical locations of heart signals. These measurements aim to provide more detailed cardiac information for patients. Participants may be monitored for safety and undergo assessments relevant to their heart condition. The total participation time covers the ECG procedure and associated evaluations on the study day.

Researchers are evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System called Vivo ISAR in patients with coronary artery stenosis. The study aims to collect clinical outcome data in real-world patients with coronary artery disease, following standard care procedures. The goal is to assess results and safety with a 12-month follow-up after treatment. Participants receive treatment using the Vivo ISAR stent device, which is designed to improve blood flow by widening narrowed coronary arteries in patients with symptomatic ischemic heart disease. The study involves patients undergoing percutaneous coronary intervention, with the Vivo ISAR stent used exclusively when stenting one or more vessels. During the study, participants will be monitored for clinical outcomes including the rate of target lesion failure within 12 months after the procedure. Researchers will collect relevant data on health status and treatment effects as part of routine clinical practice. The study is observational and follows patients over a year to evaluate the device's performance and safety in everyday medical care.

Researchers are evaluating the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients who have moderate-severe or severe mitral regurgitation and are considered high risk for surgical treatment. This study focuses on those with significant mitral valve leakage and aims to offer a less invasive treatment option compared to open-heart surgery. Patients included have symptoms classified under New York Heart Association Functional Class II, III, or ambulatory IV and have been receiving guideline-directed medical therapy for at least one month. The study involves the use of the HighLife Transcatheter Mitral Valve Replacement device, which is delivered via a transcatheter, trans-septal approach. This approach allows the valve to be replaced without open-heart surgery. Eligible patients must meet certain anatomical criteria for this valve and be assessed as high risk for surgery by a multidisciplinary Heart Team. The treatment process includes device implantation and ongoing monitoring according to the study protocol. Participants will be closely followed for safety and performance of the device, with the primary outcome being device safety assessed over 30 days. Throughout the study, patients will undergo evaluations to monitor heart function and any complications. The study requires patient willingness to participate and to comply with follow-up schedules and assessments. This research aims to provide important information about the use of this device in patients who have limited surgical options.

Researchers are evaluating the effectiveness of arginine-vasopressin (AVP) combined with hydrocortisone compared to norepinephrine in improving survival and neurological recovery 30 days after cardiac arrest in patients with hemodynamic failure. This phase 3 trial focuses on patients who have experienced post-resuscitation syndrome, which includes multiple organ failures and brain damage following successful resuscitation and restoration of spontaneous circulation after cardiopulmonary resuscitation. Patients are randomly assigned to receive AVP, hydrocortisone, their placebos, or a combination, in a 1:1:1:1 ratio. AVP is given by infusion to maintain a target mean arterial pressure of 65 mmHg for up to 3 days. Hydrocortisone is administered intravenously, starting with a 100 mg dose followed by 50 mg every 6 hours for 7 consecutive days, without tapering. The study involves 17 intensive care units in France and plans to enroll 380 patients. Participants will be closely monitored with evaluations including neurological outcomes measured at day 30. Researchers will assess survival and brain function recovery. The study also monitors safety and treatment adherence during the intervention period and follows patients through the critical post-resuscitation phase to capture relevant clinical outcomes.

Researchers are evaluating the effect of adding three sensory elements—visual, auditory, and olfactory—on reducing discomfort for adult patients hospitalized in intensive care or continuing care units. This study includes patients admitted for medical or surgical reasons, whether conscious or unconscious under mechanical ventilation. The trial is prospective, randomized, controlled, multicenter, and open-label, aiming to improve patient comfort during hospital stays in critical care environments. Participants will receive usual intensive or continuing care treatment based on their medical needs. The study intervention involves exposure to immersive sensory projections designed to engage sight, hearing, and smell. Patients admitted to these units, or their close relatives or trusted persons, will be offered participation. All medical and supportive care continues as standard practice alongside the sensory intervention. During the study, patients and their relatives will be monitored and supported by the medical team. Researchers will assess patient discomfort using the REAnimation Patient Discomfort Questionnaire after two months. Consent and understanding of the research procedures are required before participation. The total length of participation and detailed monitoring will follow hospital and study protocols to ensure safety and data collection.