Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-06 @ 2:32 AM
Study NCT ID:
NCT06590467
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abbott Structural Heart Device Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055989', 'term': 'Septal Occluder Device'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2039-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2024-09-02', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': '7 days', 'description': 'The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.'}, {'measure': 'Primary Effectiveness Endpoint', 'timeFrame': 'Baseline', 'description': 'The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Amplatzer', 'Amplatzer Septal Occluder', 'Amplatzer Multi-fenestrated (Cribriform) Occluder', 'Amplatzer Duct Occluder', 'Amplatzer Piccolo Occluder', 'Amplatzer Muscular VSD Occluder', 'Amplatzer Post-Infarct VSD Occluder', 'Amplatzer Talisman', 'Amplatzer TorqVue Delivery System', 'Amplatzer Sizing Balloon', 'Amplatzer Guidewire', 'Amplatzer Occluder devices', 'Surgical Valves', 'Epic Plus Aortic Valve', 'Epic Plus Mitral Valve', 'Epic Plus Supra Aortic Valve', 'Epic Max Aortic Valve', 'Bioprosthetic heart valve', 'Surgical tissue heart valve'], 'conditions': ['Heart Diseases', 'ASD - Atrial Septal Defect', 'VSD - Muscular Ventricular Septal Defect', 'PFO - Patent Foramen Ovale', 'PIVSD - Post Infarct Muscular Ventricular Septal Defect', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': "The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.", 'detailedDescription': 'The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:\n\n* Amplatzer portion: within 7 days post-procedure\n* Cardiac Surgery portion: within 6 months post-procedure.\n\nAll patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.\n\nThe Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.\n\nFollow-up visits should align with the site\'s routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.\n\nThe follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices\' lifetime.\n\nA surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.\n\nPatients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery cohort: consent within 6 months (183 days) of the implant procedure)', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.\n2. Subject is willing and able to comply with the site's standard of care follow-up schedule.\n3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.\n\nExclusion Criteria:\n\n1\\. Subject is participating in another clinical study that would affect the results of this Registry."}, 'identificationModule': {'nctId': 'NCT06590467', 'acronym': 'SH-Registry', 'briefTitle': 'Abbott Structural Heart Device Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Abbott Structural Heart Device Registry', 'orgStudyIdInfo': {'id': 'ABT-CIP-10415'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amplatzer', 'description': '* ASO: ≥50 cases/year\n* ASD-MF: ≥50 cases/year\n* ADO: ≥50 cases/year\n* ADO II: ≥50 cases/year\n* Piccolo: ≥50 cases/year\n* MuVSD: Up to 50 cases/year\n* PI-VSD: Up to 50 cases/year\n* Talisman/TDS: ≥100 cases/year\n* TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders\n* TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders\n* SB II:100 PFO cases/year \\& 100 ASD cases/year\n* GW: 200 cases/year', 'interventionNames': ['Device: Amplatzer™ Occlusion Devices']}, {'label': 'Cardiac Surgery', 'description': 'It is anticipated that approximately 830 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years.\n\n* Approximately 225 subjects receiving Epic Plus mitral valves\n* Approximately 150 subjects receiving Epic Plus aortic valves\n* Approximately 170 subjects receiving Epic Plus Supra aortic valves\n* Approximately 285 subjects receiving Epic Max aortic valves', 'interventionNames': ['Device: Epic™ Surgical Tissue Heart Valve devices']}], 'interventions': [{'name': 'Amplatzer™ Occlusion Devices', 'type': 'DEVICE', 'otherNames': ['Amplatzer Septal Occluder', 'Amplatzer Multi-fenestrated (Cribriform) Occluder', 'Amplatzer Duct Occluder', 'Amplatzer Piccolo Occluder', 'Amplatzer Muscular VSD Occluder', 'Amplatzer Post-Infarct VSD Occluder', 'Amplatzer Talisman', 'Amplatzer TorqVue Delivery System'], 'description': 'The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.', 'armGroupLabels': ['Amplatzer']}, {'name': 'Epic™ Surgical Tissue Heart Valve devices', 'type': 'DEVICE', 'otherNames': ['EMAX', 'E200', 'ESP200', 'Sizer Set Model E2000', 'Sizer Set Model EMAX-1000', 'Replacement Holder Handles E2000-HA and E2000-HM'], 'description': 'The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.', 'armGroupLabels': ['Cardiac Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Southern Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lars Peter Riber, Prof.', 'role': 'CONTACT'}, {'name': 'Lars Peter Riber, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '50406', 'city': 'Tartu', 'state': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Arno Ruusalepp, Prof.', 'role': 'CONTACT'}, {'name': 'Arno Ruusalepp, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '35033', 'city': 'Rennes', 'state': 'Brittan', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amedeo Anselmi', 'role': 'CONTACT'}, {'name': 'Anselmi Amedeo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Hopital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sebastien Hascoet, Dr.', 'role': 'CONTACT'}, {'name': 'Sebastien Hascoet, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Médico Chirurgical Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Zakaria Jalal, Dr.', 'role': 'CONTACT'}, {'name': 'Zakaria Jalal, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '80636', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stanimir Georgiev, Dr. med.', 'role': 'CONTACT'}, {'name': 'Stanimir Georgiev, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsches Herzzentrum München des Freistaates Bayern', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '28277', 'city': 'Bremen', 'state': 'City state Bremen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Garbade, Prof. Dr. med.', 'role': 'CONTACT'}, {'name': 'Jens Garbade, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Links der Weser', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '07747', 'city': 'Jena', 'state': 'Germany', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Torsten Doenst, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Torsten Doenst, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitatsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '38126', 'city': 'Braunschweig', 'state': 'L Saxon', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ingo Breitenbach, Dr. med.', 'role': 'CONTACT'}, {'name': 'Ingo Breitenbach, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Städt. Klinikum Braunschweig gGmbH', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Kramer, Dr. med.', 'role': 'CONTACT'}, {'name': 'Peter Kramer, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsches Herzzentrum der Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '32545', 'city': 'Bad Rothenfelde', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nicolas Doll, Prof.', 'role': 'CONTACT'}, {'name': 'Nicolas Doll, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': 'D12N512', 'city': 'Crumlin', 'state': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Damien Kenny, Prof.', 'role': 'CONTACT'}, {'name': 'Damien Kenny, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Health Ireland (CHI)", 'geoPoint': {'lat': 53.32154, 'lon': -6.31439}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Angelo Fabio D'Aiello, MD", 'role': 'CONTACT'}, {'name': "Angelo Fabio D'Aiello, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San Donato - Cardio', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Bedogni, MD', 'role': 'CONTACT'}, {'name': 'Francesco Bedogni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Annoni', 'role': 'CONTACT'}, {'name': 'Giuseppe Annoni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Citta della Salute e della Scienza di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '56126', 'city': 'Pisa', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Colli, Prof.', 'role': 'CONTACT'}, {'name': 'Andrea Colli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Roland Fiszer, Prof.', 'role': 'CONTACT'}, {'name': 'Roland Fiszer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Slaskie Centrum Chorob Serca', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Manuel Carretero Bellon', 'role': 'CONTACT'}, {'name': 'Juan Manuel Carretero Bellon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Infantil Sant Joan De Deu', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jacobo Silva Guisasola', 'role': 'CONTACT'}, {'name': 'Jacobo Silva Guisasola', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '41013', 'city': 'Seville', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Miguel Borrego Dominguez, Dr', 'role': 'CONTACT'}, {'name': 'Jose Miguel Borrego Dominguez, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Virgen de Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Gutierrez Larraya, Dr.', 'role': 'CONTACT'}, {'name': 'Federico Gutierrez Larraya, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de la Paz - Pediatrico', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SW3 6NP', 'city': 'London', 'state': 'UK', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alain Fraisse, Dr.', 'role': 'CONTACT'}, {'name': 'Alain Fraisse, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Matthew Jones, Dr.', 'role': 'CONTACT'}, {'name': 'Matthew Jones, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Laetitia Beullens', 'role': 'CONTACT', 'email': 'laetitia.beullens@abbott.com', 'phone': '+32 277 46 937'}, {'name': 'Kayla Dellefratte', 'role': 'CONTACT', 'email': 'kayla.dellefratte@abbott.com', 'phone': '+16692149748'}], 'overallOfficials': [{'name': 'Ryan Palmer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}