[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mri-imaging\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mri-imaging":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100640372","phase-resolved-functional-lung-mri-and-oscillometry-for-the-observation-of-healthy-lung-function-100640372",false,"NCT07614685","Phase Resolved Functional Lung MRI and Oscillometry for the Observation of Healthy Lung Function","PROOF","Inclusion Criteria:\n\n* Age 18 years or older\n* Ability to provide consent\n* Willingness to perform MRI and breathing test\n* Must be able to speak and understand English\n\nExclusion Criteria:\n\n* Pregnant\n* Unable or willing to provide consent or perform the required maneuvers for testing.",true,"ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","This study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects.",[25,26,27,28],"Breathing","Lung Function Decreased","MRI Imaging","Healthy","NOT_YET_RECRUITING","2026-05-20",{"date":32,"type":33},"2026-05-29","ACTUAL",{"date":35,"type":21},"2026-07-01",{"date":37,"type":21},"2028-01-01",{"name":39,"class":40},"University of Rochester","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100607528","the-magnasafe-2-registry-assessing-the-risks-of-magnetic-resonance-imaging-in-three-patient-groups-100607528","NCT07189728","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups: (1) an MRI at a Magnet Field Strength of 3-tesla, (2) a \"Mixed-vendor\" or a Same Vendor \"Mixed-component\" Platform at 1.5-tesla or 3-tesla, or (3) a System With an Abandoned, Epicardial, or Fractured Lead at 1.5-tesla.","Inclusion Criteria:\n\nPatients will be included in the registry if they fulfill all the following criteria:\n\n1. Age of 18 years or older\n2. Able to provide informed consent for entry in the research registry\n3. Have a CIED from any manufacturer implanted after 2001\n4. Have cardiac leads from any manufacturer without an implant date limitation\n5. Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology\n6. The patient is scheduled for that imaging procedure\n7. MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol\n8. In addition, groups within the protocol require that an enrolled patient will have:\n\n   1. An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.\n   2. A \"mixed-vendor\" or same vendor \"mixed-component\" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.\n   3. A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.\n\n      Exclusion Criteria:\n\n      Patients will not be included in the registry if they fulfill any of the following criteria:\n\n   \u003C!-- -->\n\n   1. A generator battery at the elective replacement indicator (ERI)\n   2. Renal insufficiency (GFR \\\u003C45 cc\u002Fmin)\n   3. In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed.\n   4. Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils)\n\n      \\-",{"count":50,"type":21},1500,"6 Months","SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a \"mixed-vendor\" or same-vendor \"mixed-component\" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined.\n\nHypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase.\n\nPurpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI.\n\nStudy Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, \"Coverage with Evidence Development (CED)\" has been requested from CMS.\n\nEnrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at \"elective replacement indicator,\" or renal insufficiency (GFR \\\u003C45 cc\u002Fmin). All participants will be required to provide informed consent for the collection of data.\n\nMethods: Patients will be enrolled in the registry at up to 30 clinical centers with: (1) an NMRC pacing system scheduled for MRI at a magnet field strength of 3-tesla, (2) an NMRC system due to a \"mixed-vendor\" or a same vendor \"mixed-component\" platform at 1.5-tesla or 3-tesla, or (3) an MRC or NMRC pacing system and an abandoned, epicardial, or fractured lead at 1.5-tesla.\n\nPrimary Endpoints: A new cardiac arrhythmia noted during the MRI scan, or a Troponin-T elevation (\\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI. Secondary Endpoints: Death, generator or lead failure requiring immediate replacement, loss of pacing capture (pacing-dependent patients), partial or full generator-electrical reset, pacing lead threshold increase of ≥1.0 V, a P-wave amplitude decrease of ≥50%, an R-wave amplitude decrease of ≥50%, and a pacing lead impedance change of ≥50 ohms from baseline.\n\nSample Size: Using an event rate limit of ≤1%, 500 cases will be needed in each group to yield a 95% confidence interval of 0 to 1.0% if no events are observed. When a total of 500 cases have been enrolled in one group, enrollment in the other groups may be continued at the discretion of the investigators. The estimated study duration is 5 years, including enrollment and data analysis.\n\nClinical Implications and Impact: The anticipated results will support an amendment to the current HRS Expert Consensus Statement (2017) and Medicare NCD (April 2018) for the patient groups in the study.",[54,27,55],"Pacemakers","Implantable Cardioverter Defibrillator (ICD)",[57,58,59,60,61],"pacemaker","MRI","implantable cardioverter defibrillator","abandoned cardiac leads","3-tesla","2025-09-22",{"date":64,"type":33},"2025-09-24",{"date":66,"type":21},"2026-01-01",{"date":68,"type":21},"2031-01-01",{"name":70,"class":40},"The Scripps Research Institute"]