[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633793":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":18,"interventions":18,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":23,"collaborators":18,"id":25,"slug":18,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":18,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":18,"maxAge":18,"enrollmentInfo":32,"targetDuration":18,"studyType":35,"phases":18,"briefSummary":36,"conditions":37,"keywords":18,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":18},{"fullName":5,"class":6},"Venus MedTech (HangZhou) Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation","The right ventricular reverse remodeling and the improvement rate of right ventricular function at 6 months after operation were defined as the 6-month follow-up The right ventricular end-diastolic volume index measured by CMR was within the normal range, that is, RVEDVI≤108mL\u002Fm2.","From enrollment to month-6 post procedure.",[14],{"measure":15,"description":16,"timeFrame":17},"adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.","1. Occurrence of the following adverse events at 6 years, 7 years, 8 years, 9 years and 10 years:\n\n   * Device migration\u002Fembolization\n   * Valvar thrombosis\n   * Thromboembolism\n   * Bleeding\n   * Paravalvular leak\n   * Endocarditis\n   * Nonstructural dysfunction\n   * Explant\n   * Hemolysis\n   * Arrhythmias\n2. Moderate or greater pulmonary regurgitation by echocardiography at 6 years, 7 years, 8 years, 9 years and 10 years.","From enrollment to 10 years post procedure.",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","OTHER","All subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).",{"type":24,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100633793",false,"NCT07531303","VenusP-Valve™ System Long-term Follow-up 6-10 Years","Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts","Inclusion Criteria:\n\n* The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site\n\nExclusion Criteria:\n\n* The investigators consider that the patients are not suitable to participate in this study.","ALL",{"count":33,"type":34},55,"ESTIMATED","OBSERVATIONAL","The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).\n\nAnnual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..",[38],"Native Right Ventricle Outflow Tract(RVOT) Dysfunction","NOT_YET_RECRUITING","2026-04-08",{"date":42,"type":43},"2026-04-15","ACTUAL",{"date":45,"type":34},"2026-05",{"date":47,"type":34},"2030-06",{"name":5,"class":6}]