Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-31 @ 11:21 PM
Study NCT ID:
NCT06818435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Myval valve and TAVI procedure', 'timeFrame': '30 days', 'description': 'Composite of:\n\n* All-cause mortality\n* All stroke\n* Acute kidney injury (stage 2, 3 and 4)\n* Bleeding (Type 3 and 4)\n* Moderate or severe paravalvular leak\n* Major vascular complications\n* Conduction disturbances resulting in new permanent pacemaker implantation'}], 'secondaryOutcomes': [{'measure': 'Safety and Performance of Myval valve and TAVI procedure', 'timeFrame': '30 days and 12 Months', 'description': '1. All-cause mortality (cardiac and non-cardiac)\n2. All stroke\n3. Acute Kidney Injury (AKI) System-Stage 2, 3 and 4\n4. Moderate or severe paravalvular leak\n5. Conduction disturbances and Arrythmias\n6. New permanent pacemaker implantation\n7. Major vascular complications\n8. Vascular and access related complications\n9. Echocardiography measurements\n10. Procedure-related assessments\n11. New York Heart Association (NYHA) Functional Classification\n12. Re-Hospitalization\n13. Bleeding (Type 3 and 4)\n14. Myocardial Infarction\n15. Length of index hospital stay\n16. Cardiac structural complications\n17. Aortic bioprosthetic valve dysfunction\n18. Bioprosthetic valve deterioration\n19. Conversion to open surgery\n20. Unplanned use of mechanical circulatory support\n21. Implantation of multiple (\\>1) transcatheter valves during the index hospitalization\n22. Valve malposition\n23. Technical success\n24. Device success\n25. Early safety'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MyPORTuVal', 'TAVI', 'Portuguese TAVI Registry'], 'conditions': ['Aortic Valve Stenosis', 'TAVI(Transcatheter Aortic Valve Implantation)']}, 'descriptionModule': {'briefSummary': 'A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.\n2. Patient has provided written informed consent as approved by the Ethics Committee (EC)\n3. Patient is willing to undergo all registry procedures and follow-up requirements\n\nExclusion Criteria:\n\n1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.\n2. Ongoing infective endocarditis or any similar infection.\n3. Pregnant or lactating females.\n4. Liver failure (Child-Pugh Class B or C)\n5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.\n6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.'}, 'identificationModule': {'nctId': 'NCT06818435', 'acronym': 'MyPORTuVal', 'briefTitle': 'Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry', 'organization': {'class': 'OTHER', 'fullName': 'Portuguese Association of Interventional Cardiology'}, 'officialTitle': 'Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry', 'orgStudyIdInfo': {'id': 'MyPTVal-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Myval THV series', 'type': 'DEVICE', 'description': 'Transcatheter Aortic Valve Implantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2790-134', 'city': 'Carnaxide', 'country': 'Portugal', 'contacts': [{'name': 'Joao de Brito, MD', 'role': 'CONTACT', 'email': 'jdbrito@netcabo.pt', 'phone': '+351210431000'}], 'facility': 'Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'zip': '3004-561', 'city': 'Coimbra', 'country': 'Portugal', 'contacts': [{'name': 'Joana Silva, Prof. Dr.', 'role': 'CONTACT', 'email': 'joanadelgadosilva@gmail.com'}], 'facility': 'Unidade Local de Saúde de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '7000-811', 'city': 'Evora', 'country': 'Portugal', 'contacts': [{'name': 'Lino Patrício, Prof. Dr.', 'role': 'CONTACT', 'email': 'linopatricio@gmail.com', 'phone': '+351 266 740 100'}], 'facility': 'Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo', 'geoPoint': {'lat': 38.56587, 'lon': -7.90405}}, {'zip': '1169-024', 'city': 'Lisbon', 'country': 'Portugal', 'contacts': [{'name': 'Duarte Cacela, MD', 'role': 'CONTACT', 'email': 'dcacela@hotmail.com', 'phone': '+351 21 359 4000'}], 'facility': 'Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'contacts': [{'name': 'Claudia Jorge, MD', 'role': 'CONTACT', 'email': 'c_jorge@sapo.pt'}], 'facility': 'Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'contacts': [{'name': 'João Silva', 'role': 'CONTACT', 'email': 'joaocebsilva@hotmail.com', 'phone': '+351 225 512 100'}], 'facility': 'Unidade Local de São João E.P.E.', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Ana Domingues', 'role': 'CONTACT', 'email': 'ana.domingues@spc.pt', 'phone': '+351217970685'}, {'name': 'Rita Calé, MD', 'role': 'CONTACT', 'email': 'ritacale@hotmail.com', 'phone': '+351217970685'}], 'overallOfficials': [{'name': 'Rui Campante Teles, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portuguese Association of Interventional Cardiology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meril Life Sciences Pvt. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}