[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Ischemic Mitral Regurgitation","Functional Mitral Regurgitation","NOT_YET_RECRUITING","2023-01-02",{"date":31,"type":32},"2023-01-04","ACTUAL",{"date":34,"type":20},"2023-09-10",{"date":36,"type":20},"2027-12-31",{"name":38,"class":39},"Mitre Medical Corp.","INDUSTRY",""]