[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mitre Medical Corp.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100392927","epicardial-mitral-touch-system-for-mitral-insufficiency-100392927",false,"NCT04396379","Epicardial Mitral Touch System for Mitral Insufficiency","ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency","ENRAPTUS","Inclusion Criteria:\n\n* Moderate or greater (2+) ischemic\n* Functional Mitral regurgitation by 2D echocardiography using an integrative method\n* Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)\n* Patient is 22 years of age or older\n* Patient is willing and able to sign Informed Consent Form\n* Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States\n\nExclusion Criteria:\n\n* Any evidence of structural (chordal or leaflet) mitral valve disease\n* Inability to derive ERO, LVESVI or LVEDVI by TTE\n* Prior surgical or percutaneous mitral valve intervention\n* Contraindication to cardiopulmonary bypass (CPB)\n* Clinical signs of cardiogenic shock\n* Treatment with chronic intravenous inotropic therapy\n* Severe, irreversible pulmonary hypertension in the judgement of the investigator\n* ST segment elevation requiring intervention within 7 days prior to randomization\n* Congenital heart disease (except PFO or ASD)\n* Evidence of cirrhosis or hepatic synthetic failure\n* Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin)\n* History of endocarditis or current endocarditis\n* Ejection fraction \\\u003C25%\n* NY heart class IV\n* MV diameters \\> 7cm\n* Any coronary artery calcification at site of placement as determined by angiogram\n* Myxomatous mitral regurgitation\n* Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)\n* Abnormal cardiac anatomy discovered prior to surgery or during procedure\n* Pericardial adhesions\n* Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)","ALL","22 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.",[27,28],"Ischemic Mitral Regurgitation","Functional Mitral Regurgitation","NOT_YET_RECRUITING","2023-01-02",{"date":32,"type":33},"2023-01-04","ACTUAL",{"date":35,"type":21},"2023-09-10",{"date":37,"type":21},"2027-12-31",{"name":39,"class":40},"Mitre Medical Corp.","INDUSTRY",""]