11 Clinical Trials for Various Conditions
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).
This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary. Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting. This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.
The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be associated with the procedure.
Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to safety concerns. Recent work in our laboratory as well as our pilot study of approximately 500 patients has shown the safety of most contemporary implanted rhythm management devices in the MRI environment given appropriate precautions. Because the investigators have completed testing in animals weighing as little as 80 lbs. without incident, the investigators feel they can safely image children at this weight or greater (Circulation 2004; 110:475-482). The goal of this study is to expand on our pilot study and to develop a protocol, consistent with the Department of Health and Human Services (DHHS) requirements, that will increase our safety experience with clinically indicated MR imaging in patients with implanted cardiac pacemakers and ICD's. This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the setting of implantable devices will be discussed and informed consent obtained. The type of device and leads will be ascertained. Patients will be monitored by a physician or a Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming during the study. When imaging children who meet age and weight criteria, a physician will be present during the entire study. Fellow and attending radiology and electrophysiology support will be available in house in all cases. Standard device testing including battery voltages, thresholds, sensing and lead impedances will be measured.
This trial is a prospective, multi-center, randomized study of patients with coronary artery disease (CAD) and mild to moderate left ventricular (LV) dysfunction. The primary objective of this study is to test the hypothesis that Implantable Cardioverter Defibrillator (ICD) therapy in combination with medical therapy in patients with an infarct size greater than or equal to 10% of the left ventricular mass improves long term survival compared to medical therapy alone. In addition to the 2-arm randomized trial, the study will also include a non-investigational registry of non-randomized patients.
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).