Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-27 @ 5:05 AM
Study NCT ID:
NCT03110861
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2017-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D011666', 'term': 'Pulmonary Valve Stenosis'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012092', 'term': 'Replantation'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic functional improvement at 6month', 'timeFrame': '6 months', 'description': 'Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction \\<20% by cardiac magnetic resonance (MR).'}, {'measure': 'Procedural / Device related serious adverse events at 6month', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': '5 days', 'description': 'Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient \\<35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.'}, {'measure': 'Hemodynamic function', 'timeFrame': '5 years', 'description': 'Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization.'}, {'measure': 'Severity of pulmonary regurgitation', 'timeFrame': '5 years'}, {'measure': 'New York Heart Association (NYHA) functional classification', 'timeFrame': '5 years'}, {'measure': 'Stent fracture', 'timeFrame': '5 years', 'description': 'Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).'}, {'measure': 'Catheter reintervention on TPV', 'timeFrame': '5 years'}, {'measure': 'Reoperation', 'timeFrame': '5 years'}, {'measure': 'Procedural / Device related serious adverse events', 'timeFrame': '5 years'}, {'measure': 'Death (all cause / procedural / device-related)', 'timeFrame': '5 years'}, {'measure': 'Other adverse events', 'timeFrame': '5 years'}, {'measure': 'Pulmonary regurgitant fraction', 'timeFrame': '6 months', 'description': 'Pulmonary regurgitant fraction will be measured by cardiac MRI.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Defect', 'Pulmonary Valve; Insufficiency, Congenital', 'Pulmonary Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.', 'detailedDescription': 'The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight greater than or equal to 30 kilograms\n* Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \\>35mmHg by echocardiography\n* pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm\n* Patient willing to provide written informed consent and comply with follow-up requirements\n\nExclusion Criteria:\n\n* Pre-existing mechanical heart valve in any position\n* Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)\n* Coronary artery compression\n* A known hypersensitivity to Aspirin or Heparin\n* Immunosuppressive disease\n* Active infectious disease (e.g. endocarditis, meningitis)\n* Estimated survival less than 6 months\n* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.'}, 'identificationModule': {'nctId': 'NCT03110861', 'briefTitle': 'Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taewoong Medical Co., Ltd.'}, 'officialTitle': "A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease", 'orgStudyIdInfo': {'id': 'TPV-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsta® Transcatheter Pulmonary Valve', 'description': 'Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)', 'interventionNames': ['Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement']}], 'interventions': [{'name': 'Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement', 'type': 'DEVICE', 'description': 'Pulsta® Transcatheter Pulmonary Valve Replacement', 'armGroupLabels': ['Pulsta® Transcatheter Pulmonary Valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Haehak-ro Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14754', 'city': 'Bucheon-si', 'state': 'Hohyun-ro, Sosa-gu', 'country': 'South Korea', 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Ilwon-ro, Gangnam-gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Olympic-ro, Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Yonsei-ro, Seodaemun-gu', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Gi Beom Kim, phD. MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taewoong Medical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}