[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"right-to-left-shunt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:right-to-left-shunt":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100588203","phase-3-comparing-the-safety-and-efficacy-of-asi-02-to-agitated-saline-for-suspected-right-to-left-shunt-100588203",false,"NCT06938347","Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt","A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt","ENHANCE","Inclusion Criteria:\n\n1. Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt\n2. Patient must be at least 18 years of age inclusive, at the time of signing the informed consent\n3. Able to communicate effectively with trial personnel\n\nExclusion Criteria:\n\n1. Female patients who are pregnant or lactating. All women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening regardless of contraceptive use history\n2. WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to ASI-02 dose administration\n3. Allergy to polysorbate 80 (PS-80)\n4. American Society of Anesthesiologists (ASA) physical status classification IV, V, or VI, except that participants with ASA physical status IV due solely to recent suspected transient ischemic attack or cerebrovascular accident are eligible for inclusion\n5. Current illness or pathology that in the opinion of the investigator would prevent undergoing investigational product administration due to a significant safety risk to the patient\n6. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)\n7. Unstable cardiovascular status defined as:\n\n   1. myocardial infarction or unstable angina pectoris within 6 months prior to procedure day\n   2. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease\n   3. clinically significant congenital heart defects (excluding an atrial septal defect \\[ASD\\], patent foramen ovale \\[PFO\\], or pulmonary arteriovenous malformation \\[PAVM\\])\n   4. current uncontrolled cardiac arrhythmias causing clinical symptoms requiring medical intervention or hemodynamic compromise\n   5. acute pulmonary embolus or pulmonary infarction\n   6. acute myocarditis or pericarditis\n   7. acute aortic dissection\n   8. untreated atrial fibrillation\n8. Any major surgery within 30 days prior to screening\n9. Participation in any investigational drug, device, or placebo study within 30 days prior to screening\n10. Vulnerable adult participant populations (e.g., incarcerated or cognitively challenged adults)","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.",[27],"Right-To-Left Shunt",[29,30,31,32,33,34],"Saline Contrast","Saline Contrast Transthoracic Echocardiogram","Transthoracic Echocardiogram","Agitated Saline Standard of Care","Echocardiogram","Transpulmonary Shunt","RECRUITING","2026-06-04",{"date":38,"type":39},"2026-06-05","ACTUAL",{"date":41,"type":39},"2025-11-05",{"date":43,"type":21},"2026-06",{"name":45,"class":46},"Agitated Solutions, Inc.","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100632914","pulmonary-embolism-and-right-to-left-shunts-100632914","NCT07519876","Pulmonary Embolism and Right-to-Left Shunts","PEaRLS","Inclusion Criteria:\n\n1. Age ≥18\n2. Acute pulmonary embolism (any grade\u002Fsize)\n3. Patient or legally authorized representative is able to provide consent to participate in the study\n\nExclusion Criteria:\n\n1. Patients who, in the opinion of the study investigators, are unable to participate in required study activities\n2. Patients unable to undergo MRI imaging",{"count":56,"type":21},256,"OBSERVATIONAL","Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people. This is called a \"patent\" foramen ovale, or PFO. In people with a PFO it is possible for a blood clot in a vein to enter the heart, pass through the opening, and then go into an artery - this is referred to as a paradoxical embolism which passes through a \"Right-to-Left Shunt,\" or RLS. If this occurs, the blood clot can cause a stroke. The most common RLS (more than 90%) is a PFO. Much rarer causes include other types of holes in the heart (like an atrial septal defect, or ASD), or a vascular communication in the lungs (like a pulmonary arteriovenous malformation, or AVM).\n\nWe are investigating whether people with a PE are at higher risk of stroke if they happen to have an RLS compared to PE patients who don't have an RLS. This study will simply observe and compare the differences in stroke-related outcomes between those 2 groups.\n\nParticipation in the study last roughly 90-days and includes the following activities:\n\n* The study team will review your medical records to collect general information such as your age, sex, race\u002Fethnicity, height, weight, medications, medical history, and other medical information\n* Magnetic Resonance Imaging (MRI) of your brain will be done as soon as possible following your enrollment in the study. For more information on MRI scans, please see the \"MRI scan\" section below.\n* A Transcranial Doppler (TCD) with bubble study will be performed to determine if an opening is present in your heart or lungs. TCD is performed using ultrasound. A contrast called agitated saline will be injected into your vein for this test.\n* You will be asked to return for a follow-up visit 90 days after your pulmonary embolism. At this visit, the following will occur:\n\n  1. A second MRI of your brain will be performed.\n  2. You will complete a questionnaire to evaluate whether you may have had a stroke since being discharged from the hospital\n  3. You will meet with a member of the study team who will collect information about your health status.",[60,61,62,63,64,65],"Pulmonary Embolism (PE)","Right-to-Left Shunt","Stroke","Atrial Septal Defects","Patent Foramen Ovale (PFO)","Pulmonary Arteriovenous Malformation",[67,68,61,69,70,62,63,71],"Pulmonary Embolism","PE","PFO","ASD","Patent Foramen Ovale","2026-04-02",{"date":74,"type":39},"2026-04-09",{"date":76,"type":39},"2026-01-30",{"date":78,"type":21},"2028-01",{"name":80,"class":81},"Tufts Medical Center","OTHER",1,"Right to Left Shunt"]