Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-24 @ 3:23 AM
Study NCT ID:
NCT03910751
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety endpoint', 'timeFrame': '30 days', 'description': 'Composite of all-cause mortality, any stoke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular, major access related, major cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation and valve-related dysfunction requiring repeat procedure at 30 days'}, {'measure': 'Primary efficacy endpoint at 30 days', 'timeFrame': '30 days', 'description': 'Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score \\<45 or decline from baseline \\>10 points at 30 days'}, {'measure': 'Primary efficacy endpoint at 1 year', 'timeFrame': '1 year', 'description': 'Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score \\<45 or decline from baseline \\>10 points at 1 year'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Stroke', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Life threatening bleeding', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Acute kidney injury', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Coronary artery obstruction requiring intervention', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Major vascular complication', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Valve related dysfunction requiring repeat procedure', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'All-cause rehospitalization', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Rehospitalization for valve-related symptoms or worsening congestive heart failure', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'New permanent pacemaker implantation', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'NYHA heart failure class III or IV', 'timeFrame': '30 days and 1 year', 'description': 'As defined by the most recent VARC document'}, {'measure': 'Patient reported Quality of Life', 'timeFrame': '30 days and 1 year', 'description': 'As measured by the EQ5D-5L quality of life questionnaire'}, {'measure': 'Patient reported Quality of Life', 'timeFrame': '30 days and 1 year', 'description': 'As measured by the KCCQ quality of life questionnaire'}, {'measure': 'Categorical cost analysis', 'timeFrame': '30 days', 'description': 'Derived from length of stay on Intensive care unit and general ward'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TAVI', 'TAVR', 'Early discharge', 'ACURATE Neo'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.', 'detailedDescription': 'In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '250 patients with severe AS and selected for TF-TAVI with the ACURATE Neo valve and eligible for early discharge within 48 hours post TAVI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for ACURATE Neo valve implantation\n* Patient agrees to follow-up duration\n* Patient is able to understand and sign written informed consent\n\nExclusion Criteria:\n\n* BMI \\> 35\n* Pregnancy\n\nCardiac\n\n* Moderate to severely impaired left ventricular ejection fraction (LVEF \\<35%)\n* Mitral regurgitation \\> moderate\n* Pulmonary hypertension (sPAP \\> 60mmHg)\n* No complex coronary artery disease\n* Untreated high degree AV-block or RBBB\n\nPulmonary\n\n* COPD Gold \\> 2\n\nKidney function\n\n* GFR \\< 35ml/min\n\nFrailty\n\n* Inappropriate social support and/or (familial) care\n* Patient is walking aid dependent\n\nTAVI strategy\n\n* Presence of severe peripheral artery disease\n* Transfemoral approach not possible\n\nFollow up\n\n* Inability to adhere to follow-up'}, 'identificationModule': {'nctId': 'NCT03910751', 'acronym': 'POLESTAR', 'briefTitle': 'POLESTAR Trial - An International Multi-center Early Discharge TAVI Program', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program', 'orgStudyIdInfo': {'id': 'POLESTAR_EMC2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis', 'type': 'DEVICE', 'description': 'Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'ASZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'New Westminster', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'University Hospital Sussex NHS Foundation Trust', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Nicolas Van Mieghem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicolas van Mieghem', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}