[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635687":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":58,"collaborators":19,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":19,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":19,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":86,"whyStopped":19,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"IASD therapy in HFrEF","All patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use.",[12,13],"Other: cardiac MRI","Other: Functional Testing",[15,20],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"cardiac MRI","Cardiac Imaging: Multiparametric cardiac MRI (cMRI) and Phosphorus-31 Magnetic Resonance Spectroscopy (³¹P-MRS) at rest and during cycle ergometry to evaluate ventricular volumes, pressures, and myocardial energy efficiency",[9],null,{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":19},"Functional Testing","Cardiopulmonary exercise testing (CPET) to quantify functional capacity via VO2 max and standardized symptom assessment in the heart failure unit.",[9],[25],{"name":26,"affiliation":27,"role":28},"Malte Kelm, MD","Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":19,"email":34},"Amin Polzin, MD","CONTACT","+49 2118105187","ctu@med.uni-duesseldorf.de",{"name":36,"role":32,"phone":33,"phoneExt":19,"email":37},"Lisa Dannenberg, MD","LisaKristina.Dannenberg@med.uni-duesseldorf.de",[39],{"facility":40,"status":19,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University Hospital Duesseldorf","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],6.77927,51.22319,{"lat":50,"lon":49},[53,55],{"name":31,"role":54,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":57,"phone":19,"phoneExt":19,"email":19},"Mareike Cramer, MD","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100635687","relieve-metab-study-100635687",false,"NCT07555925","RELIEVE METAB Study","Interatrial Shunt Device (IASD) Treatment in Symptomatic Heart Failure With Reduced Left Ventricular Ejection Fraction (HFrEF) Alleviates Elevated Myocardial Left Ventricular Pressures, Improves Myocardial Mitochondrial Function and Promotes Regional and Global Myocardial Recovery","Inclusion Criteria:\n\n1. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40%\n2. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU.\n3. Symptoms: NYHA Class III\n4. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT)\n5. Biomarkers: NTproBNP ≥ 1,200 pg\u002Fml\n6. Age 18 years or older\n7. Subject has signed informed consent form and is willing and able to attend all follow-up visits and is physically capable of performing all tests.\n\nExclusion Criteria:\n\n1. Hemodynamics: Resting SBP \\\u003C 90 or \\> 160 mmHg\n2. Severe PH (PASP \\>70 mmHg, PVR \\> 4 Wood Units)\n3. Anatomy\u002FStructure:\n\n   * intracardiac thrombus\n   * Severe RV dysfunction (TAPSE \\\u003C12 mm or RVFAC ≤25%)\n   * LVEDD \\> 8 cm\n   * Significant ASD or PFO\n4. Valvular Disease:\n\n   * Severe, untreated mitral stenosis or aortic stenosis or regurgitation\n   * Mitral repair device \\\u003C3 months prior to enrollment\n5. Recent Events:\n\n   * ACS, PCI, Cardiac Surgery (\\\u003C 3 months prior to enrollment)\n   * CAD requiring revascularization\n   * Stroke, TIA, PE, Thrombosis (\\\u003C 6 months prior to enrollment)\n6. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI\n7. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint\n8. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits\n9. Any non-cardiac condition with life expectancy \\\u003C1 years (e.g., cirrhosis, cancer not in remission, etc.)\n10. Subject belongs to a vulnerable population","ALL","18 Years",{"count":70,"type":71},15,"ESTIMATED","INTERVENTIONAL",[74],"NA","This prospective, single-center post-market-follow-up study aims to fill knowledge gaps by combining advanced cardiac MRI\u002FMRS with systemic mitochondrial assays and exercise testing to characterize the energetic and functional impact of IASD therapy in HFrEF patients.",[77],"Heart Failure With Reduced Ejection Fraction (HFrEF)",[79,80,81,82,83,84,85],"Interatrial Shunt Device (IASD)","Ventura Shunt","Myocardial Energetics","Mitchondrial Function","MRI","CMR","MRS","NOT_YET_RECRUITING","2026-04-22",{"date":89,"type":90},"2026-04-29","ACTUAL",{"date":92,"type":71},"2026-06-01",{"date":94,"type":71},"2027-07-01",{"name":5,"class":6},1]