[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VisCardia Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100558555","synchronized-diaphragmatic-stimulation-in-symptomatic-heart-failure-100558555",false,"NCT06552637","Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure","RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure","RECOVER-HF","Inclusion Criteria:\n\n* NYHA classes II\u002FIII on optimal Guideline Directed Medical Therapy (GDMT)\n* QRS duration ≤ 130 ms\n* EF≤ 40%\n\nExclusion Criteria:\n\n* Baseline 6 minute walk test \\> 500 meters or \\\u003C 200 meters\n* NT-proBNP\\\u003C 250 if on loop diuretics, or NT-proBNP \\\u003C 500 if not on loop diuretics\n* Supine resting heart rate \\> 140 bpm\n* Systolic blood pressure \\\u003C 80 mmHg or \\> 170 mmHg\n* Serum creatinine \\> 2.5 mg\u002FdL\n* Serum hepatic function 3x ULN\n* Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA\u002FTIA, persistent AF (\\> 24 hours), symptomatic NSVT or DCCV\n* Any inotropic drug treatment within the previous 3 months\n* Bradycardia (heart rate \\\u003C 50 beats\u002Fmin), atrial arrhythmias with rates \\> 100 beats\u002Fmin, sustained ventricular tachycardia or frequent ventricular ectopy \\>10% present during screening\n* Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \\> 10% documented within the previous 3 months\n* Reversible non-ischemic cardiomyopathy\n* Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:\n\n  1. Greater than mild mitral valve stenosis\n  2. Greater than moderate mitral valve regurgitation\n  3. Greater than mild tricuspid valve stenosis\n  4. Greater than moderate-severe tricuspid valve regurgitation\n  5. Greater than moderate aortic stenosis\n  6. Greater than moderate aortic regurgitation\n  7. Greater than mild-moderate pulmonic stenosis\n  8. Greater than moderate pulmonic regurgitation\n* Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \\>70 mmHg at rest\n* Severe COPD, other respiratory or lung diseases where FEV \\\u003C 50%\n* Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months\n* Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray\n* Pericardial disease\n* Diabetic neuropathy\n* Existing diaphragmatic stimulation for respiration assist\n* Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); or CRT that is indicated or implanted and functional\n* Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician\n* Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.\n* Previous open laparotomy within 1 year\n* Previous thoracic or abdominal organ transplant\n* Drug induced immuno-suppression\n* Body mass index \\> 40\n* Enrollment in a concurrent investigation \u002F clinical study\n* Having a life expectancy of \\\u003C1 year due to any condition\n* Pregnant or planning a pregnancy during the study period\n* Known allergies to implantable device materials\n* History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months","ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"NA","RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.",[27],"Heart Failure With Reduced Ejection Fraction",[29,30,31,32],"Heart Failure","Heart Disease","Synchronized Diaphragmatic Stimulation","Implantable Heart Failure Device Therapy","RECRUITING","2026-03-27",{"date":36,"type":37},"2026-03-31","ACTUAL",{"date":39,"type":21},"2026-04-30",{"date":41,"type":21},"2029-12",{"name":43,"class":44},"VisCardia Inc.","INDUSTRY",""]