Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT05844969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '12 months', 'description': 'To assess whether patients with bicuspid aortic valves that received a SAPIEN 3 / Ultra THV suffered from fewer complications\n\n* if valve size was identical to the one determined using the circle method compared to\n* a case where circle method derived valve size is different from the actually implanted valve'}], 'secondaryOutcomes': [{'measure': 'Sizing with Circle Method', 'timeFrame': '12 months', 'description': 'To develop recommendations on how to size the valve using the circle method.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis With Bicuspid Valve']}, 'descriptionModule': {'briefSummary': 'The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).\n\nThe main aims are:\n\n* to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications\n\n * if valve size was identical to the one determined using the circle method compared to\n * a case where circle method derived valve size is different from the actually implanted valve\n* to develop recommendations on how to size the valve using the circle method.', 'detailedDescription': 'The bicuspid aortic valve (BAV) is the most common heart valve abnormality and is associated with a number of cardiac complications, including infective endocarditis, aortic dissection, aortic dilatation, and the development of severe aortic stenosis (AS). Due to its anatomical characteristics BAV has been considered a contraindication to transcatheter aortic valve implantation (TAVI), a standard treatment of AS. However, several recent trials have presented promising results indicating TAVI to be a safe alternative to surgery for low risk patients and more patients with BAV have been considered for TAVI.\n\nThere are several sizing techniques for TAVI in BAV, including an annular sizing, a supra-annular sizing, and a balloon sizing, yet there is still no consensus on the most appropriate technique. Although annular sizing remains the major approach in most patients with BAV, some BAV anatomies may profit from the supra-annular sizing. Recently published consensus for sizing and positioning the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve (THV) in BAV describes the anatomical features that influence sizing optimization. The novel circle technique has also been proposed in the presence of the unique anatomical factors and sizing at the supra-annular level. This method is particularly helpful for visually identifying anatomic features, indicating the sealing zone at the commissures, visually reassuring of the size and position, and treating patients with large annuli. Currently, there are limited data validating the circle method for identifying sizing and positioning for TAVI in BAV patients.\n\nIn this non-interventional, retrospective, multicenter data collection and analysis we aim to validate the circle method for sizing and positioning in bicuspid aortic valves.\n\nDue to the non-interventional character of the project, no additional burden will be put on the patients eligible for inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with bicuspid valve disease who underwent aortic valve replacement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)\n* Computed Tomography data available\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT05844969', 'briefTitle': 'Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection', 'organization': {'class': 'NETWORK', 'fullName': 'Institut für Pharmakologie und Präventive Medizin'}, 'officialTitle': 'Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves', 'orgStudyIdInfo': {'id': 'CMOP'}}, 'contactsLocationsModule': {'locations': [{'zip': 'CB20AY', 'city': 'Cambridge', 'country': 'United Kingdom', 'contacts': [{'name': 'Pierluigi Costanzo, Dr.', 'role': 'CONTACT', 'email': 'p.costanzo@nhs.net'}], 'facility': 'Royal Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G814DY', 'city': 'Clydebank', 'country': 'United Kingdom', 'contacts': [{'name': 'Angie Ghattas, Dr.', 'role': 'CONTACT', 'email': 'Angie.ghattas@gjnh.scot.nhs.uk'}], 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}, {'zip': 'SE17EH', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Ioannis Lianos, Dr.', 'role': 'CONTACT', 'email': 'ioannis.lianos@gstt.nhs.uk'}, {'name': 'Tiffany Patterson, Dr.', 'role': 'CONTACT', 'email': 'Tiffany.patterson@gstt.nhs.uk'}], 'facility': "Guy's and St Thomas NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'BN112DH', 'city': 'Worthing', 'country': 'United Kingdom', 'contacts': [{'name': 'David Hildick-Smith, Prof. Dr.', 'role': 'CONTACT', 'email': 'david.hildick-smith@nhs.net'}, {'name': 'Timothy Bagnall', 'role': 'CONTACT', 'email': 'timothy.bagnall@nhs.net'}], 'facility': 'University Hospitals Sussex NHS Foundation Trust', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'centralContacts': [{'name': 'Marie F Zielinski', 'role': 'CONTACT', 'email': 'marie.zielinski@ippmed.de', 'phone': '+49 4471 850 3326'}, {'name': 'Claudia M Lüske, Dr.', 'role': 'CONTACT', 'email': 'claudia.lueske@ippmed.de', 'phone': '+49 4471 850 3324'}], 'overallOfficials': [{'name': 'Pierluigi Costanzo, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal Papworth Hospital NHS Foundation Trust'}, {'name': 'Ioannis Lianos, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas NHS Foundation Trust"}, {'name': 'Tiffany Patterson, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas NHS Foundation Trust"}, {'name': 'Timothy Bagnall, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Sussex NHS Foundaton Trust'}, {'name': 'Angie Ghattas, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Jubilee National Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only anonymized, aggregated data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Pharmakologie und Präventive Medizin', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}