[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558555":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":66,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":40,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":48,"whyStopped":40,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"VisCardia Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Device and Medical Management","EXPERIMENTAL","* Subjects will be implanted with the VisONE System programmed to deliver SDS (Therapy On) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \\[AHA\\] \u002F American College of Cardiology \\[ACC\\] guidelines) including those drugs to be determined by the subject's physician\n* Assigned Interventions:\n\n  * Device: VisONE System (SDS)\n  * Drug: Medical Management",[13],"Device: Synchronized Diaphragmatic Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Medical Management","SHAM_COMPARATOR","* Subjects will be implanted with the VisONE System programmed not to deliver SDS (Therapy Off) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \\[AHA\\] \u002F American College of Cardiology \\[ACC\\] guidelines) including those drugs to be determined by the subject's physician\n* Assigned Interventions:\n\n  * Drug: Medical Management",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Synchronized Diaphragmatic Stimulation","Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.",[9,15],[26,27,28,29],"Asymptomatic Diaphragmatic Stimulation","SDS","ADS","VisONE SDS",[31],{"name":32,"affiliation":33,"role":34},"Lee R Goldberg, MD","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Patricia Arand, Ph.D.","CONTACT","5034313823",null,"arandp@viscardia.com",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Peter Bauer, Ph.D.","5034313824","bauerp@viscardia.com",[47],{"facility":33,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-75.16362,39.95238,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":40,"email":64},"Aditya Parikh, MD","(215) 615-4949","aditya.parikh@pennmedicine.upenn.edu",{"name":62,"role":34,"phone":40,"phoneExt":40,"email":40},{"type":67,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[69,71],{"name":70,"class":6},"Clinical Accelerator",{"name":72,"class":73},"Duke Clinical Research Institute","OTHER","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":85,"type":86},270,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92],"Heart Failure With Reduced Ejection Fraction",[94,95,22,96],"Heart Failure","Heart Disease","Implantable Heart Failure Device Therapy","2026-03-27",{"date":99,"type":100},"2026-03-31","ACTUAL",{"date":102,"type":86},"2026-04-30",{"date":104,"type":86},"2029-12",{"name":5,"class":6},1]