[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Occlutech International AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":182},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,77,91,129,161],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100393633","the-after-registry---follow-up-study-to-monitor-the-efficacy-and-safety-of-the-occlutech-afr-in-heart-failure-patients-100393633",false,"NCT04405583","The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients","A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients","AFR Registry","Inclusion Criteria:\n\n1. Written, informed consent\n2. Age ≥18 years\n3. Presence of chronic symptomatic HF (NYHA class ≥ 2)\n4. Left Atrial Pressure (LAP) \\> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\\*\n5. LVEF ≥ 15%. If LVEF is \\>40% (HFpEF), BMI corrected\\*\\* NT-pro-BNP must be elevated ≥ 125 pg\u002FmL. (BNP \\>35 pg\u002FmL) or ≥ 365pg\u002Fml (BNP \\> 105 pg\u002FmL) for patients with atrial fibrillation (AF)\n6. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C 1 year, or advanced heart failure defined as ACC\u002FAHA Stage D heart failure, or listed for heart transplantation at time of baseline visit\n2. Evidence of right heart failure defined (by ECHO) as:\n\n   1. Severe Right Ventricular Dysfunction (TAPSE \\\u003C 14 mm)\n   2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)\n   3. Severe pulmonary hypertension (PASP \\> 60 mm Hg)\n3. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation\n4. Uncontrolled hypertension, Systolic Blood Pressure of \\>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.\n5. Uncontrolled atrial fibrillation with resting heart rate \\>110bpm, despite medical therapy\n6. Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease\n7. Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.\n8. Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device\n9. Current atrial septal defect, or anatomical anomaly (including \\> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum\n10. Clinically significant valvular heart disease:\n\n    1. regurgitation grade ≥3+ or\n    2. severe stenosis of mitral or tricuspid valves, or\n    3. significant stenosis of aortic valves\n11. Prior diagnosis of primary pulmonary hypertension\n12. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration\n13. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding\n14. Myocardial Infarction (MI) and\u002For coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent.\n15. ICD or right sided pacemaker placement within 2 months\n16. Clinically significant coagulation disorder, at discretion of investigator\n17. Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment\n18. Chronic kidney disease currently requiring dialysis\n19. Allergy to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials, if not medically manageable\n20. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy\n21. Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator\n22. Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator\n\nNote: \\* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken\n\n\\*\\*\"Corrected\" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg\u002Fm2 in body mass index (BMI) above a reference BMI of 20kg\u002Fm2)","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","3 Years","OBSERVATIONAL","This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.",[26],"Heart Failure",[28,29,30,31,32,33,34,35,36,37,38,15],"Occlutech AFR","Atrial Flow Regulator","Interatrial shunt device","Heart failure","HFrEF","HFpEF","Left-to-right shunt","Balloon atrial septostomy","MACNE","Device embolization","AFR","RECRUITING","2026-06-05",{"date":42,"type":43},"2026-06-08","ACTUAL",{"date":45,"type":43},"2020-10-28",{"date":47,"type":21},"2031-06",{"name":49,"class":50},"Occlutech International AB","INDUSTRY",36,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100633875","occlutech-afr-fontan-study-100633875","NCT07532369","Occlutech AFR Fontan Study","Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population","Inclusion Criteria:\n\n* The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA).\n* The candidate\u002Fcandidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent.\n\nExclusion Criteria:\n\n* If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included",{"count":60,"type":21},25,"The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process.\n\nThe scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device.\n\nThe objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.",[63,64,65,66],"Failure of Fontan Type Circulation","Fenestration","Univentricular Heart","Congenital Anomaly","NOT_YET_RECRUITING","2026-04-08",{"date":70,"type":43},"2026-04-15",{"date":72,"type":21},"2026-05-01",{"date":74,"type":21},"2026-09",{"name":49,"class":50},7,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":4,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":4,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":89,"locationsCount":90},"100625355","expanded-access-of-occlutechs-atrial-flow-regulator-100625355","NCT07421557","Expanded Access of Occlutech's Atrial Flow Regulator","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","Occlutech AFR use allowed per FDA's Expanded Access program.","AVAILABLE","2026-02-12",{"date":88,"type":43},"2026-02-19",{"name":49,"class":50},1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100464565","follow-up-study-to-monitor-the-efficacy-and-safety-of-the-occlutech-mvsd-cases-100464565","NCT05329350","Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases","A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects","mVSD Registry","Inclusion Criteria\n\n* A participant will be eligible for study participation if he\u002Fshe meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.\n* Any age\n* Male or female.\n* Patients understand the nature of the study and provide their informed consent to participation.\n* Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nContraindication\n\n* Hemodynamically relevant VSD shunt\n* Congestive heart insufficiency\n* Recurrent respiratory infections\n* Failure to thrive.\n* Significant left ventricle (LV) enlargement\n* Significant left atrium (LA) enlargement\n* Other clinical indication\n\nExclusion Criteria\n\nThe device is contraindicated for participants known to have any of the following:\n\n⦁Active bacterial infections\n\n* Active infection at the time of implantation\n* Allergy to antiplatelet or anticoagulant therapy\n* Allergy to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials\n* Any type of serious infection 1 month before the procedure\n* The aortic rim of less than 2 mm\n* Demonstrated intracardiac thrombi on echocardiography\n* Malignancy where life expectancy is less than 3 years\n* mVSD diameter \\> 20 mm\n* Perimembranous VSD\n\nPost-MI VSD\n\n* Recent myocardial infarction or a surgical bypass operation in the last 30 days\n* Sepsis (local or generalized)\n* Septal thickness \\> 7 mm in the area of the Occluder placement","3 Months","80 Years",{"count":102,"type":21},50,"The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.\n\nThe objectives of the study are:\n\n* To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.\n* To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.",[105],"Muscular Ventricular Septal Defect",[107,108,109,110,111,112,113,114,115,116,117,118,119],"mVSD Occluder","mVSD","Occlutech","Occlutech mVSD Occluder","Muscular ventricular septal defect closure","Transcatheter closure","Percutaneous occlusion","Periventricular closure","Post-market clinical follow-up","PMCF","Congenital heart defect","Structural heart disease intervention","Echocardiography follow-up","2026-01-29",{"date":122,"type":43},"2026-02-02",{"date":124,"type":43},"2022-03-03",{"date":126,"type":21},"2029-10-01",{"name":49,"class":50},5,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":136,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100459602","post-marketing-clinical-follow-up-study-to-evaluate-efficacy-and-safety-of-the-occlutech-pda-occluder-in-patients-with-patent-ductus-arteriosus-defects-100459602","NCT05264753","Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects","A Multicenter, International, Prospective, Retrospective, Post Marketing Clinical Follow Up Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects","Inclusion Criteria:\n\n* A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.\n* Male or female subjects.\n* Subjects or their parents\u002Fguardians understanding the nature of the study and providing their informed consent to participation.\n* Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nExclusion Criteria:\n\nContraindications as laid down in the IFU:\n\n* Silent ductus or serious pulmonary hypertension:\n* Pulmonary Vascular Resistance (PVR) \\> 8 Wood Units\n* Presence of a known coagulation disorder\n* Thrombus at the position allocated for the implantation\n* A vein thrombosis in the blood vessels chosen for the introducing system\n* An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.\n* Nitinol intolerance (nickel or titanium)\n* Contrast medium intolerance\n* Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath",{"count":137,"type":21},255,"This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline\u002Fimplantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.",[140],"Patent Ductus Arteriosus",[142,143,144,145,146,147,116,148,149,150,119,151],"Occlutech PDA Occluder","Patent ductus arteriosus closure","Transcatheter PDA occlusion","Percutaneous catheter-based intervention","Occluder device","Post-marketing clinical follow-up","Prospective and retrospective study","Multicenter international study","Efficacy and safety","Pediatric cardiology","2026-01-24",{"date":154,"type":43},"2026-01-27",{"date":156,"type":43},"2021-12-20",{"date":158,"type":21},"2029-11-25",{"name":49,"class":50},15,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":168,"targetDuration":170,"studyType":23,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":51},"100452663","access-registry-a-post-market-follow-up-study-to-monitor-the-safety-performance-and-usability-of-occlutech-accessory-medical-devices-100452663","NCT05174442","ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices","A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices:Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB) Used During to Implantation Procedures of Cardiac Implant Devices","Inclusion Criteria:\n\n* Inclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use for accessory medical devices and cardiac implant devices.\n\nAll subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included\n\nExclusion Criteria:\n\n* Exclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use and if applicable in the corresponding protocol of the investigation on the Occlutech implant devices.",{"count":169,"type":21},685,"6 Months","The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories \"Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)\" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.",[173],"Heart Diseases","2025-12-03",{"date":176,"type":43},"2025-12-04",{"date":178,"type":43},"2021-10-14",{"date":180,"type":21},"2027-01-01",{"name":49,"class":50},""]