Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-15 @ 7:20 PM
Study NCT ID:
NCT04735003
Status:
RECRUITING
Last Update Posted:
2021-02-02
First Post:
2021-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcatheter Interventions for Tricuspid Insufficiency in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2021-01-16', 'studyFirstSubmitQcDate': '2021-01-30', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '1-year'}, {'measure': 'Cardiovascular death or heart failure hospitalization', 'timeFrame': '1-year'}], 'secondaryOutcomes': [{'measure': 'Changes in tricuspid regurgitation degree', 'timeFrame': '30-day, 1-year and 5-year'}, {'measure': 'Changes in NYHA class', 'timeFrame': '30-day, 1-year and 5-year'}, {'measure': 'Changes in right ventricular dimensions and function', 'timeFrame': '30-day, 1-year and 5-year'}, {'measure': 'Changes in liver and kidney function', 'timeFrame': '30-day, 1-year and 5-year'}, {'measure': 'Changes in medical therapy (i.e. diuretic dose)', 'timeFrame': '30-day, 1-year and 5-year'}, {'measure': 'All-cause death', 'timeFrame': '30-day'}, {'measure': 'All-cause death', 'timeFrame': '5-year'}, {'measure': 'Cardiovascular death or heart failure hospitalization', 'timeFrame': '30-day'}, {'measure': 'Cardiovascular death or heart failure hospitalization', 'timeFrame': '5-year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)\n2. Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.\n\nExclusion Criteria:\n\n1. Valve anatomy unsuitable for transcatheter tricuspid valve interventions.\n2. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT04735003', 'acronym': 'TRIC-IT', 'briefTitle': 'Transcatheter Interventions for Tricuspid Insufficiency in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study', 'orgStudyIdInfo': {'id': '581011977013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter tricuspid valve interventions', 'type': 'DEVICE', 'description': 'Transcatheter repair or replacement to treat tricuspid regurgitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marianna Adamo', 'role': 'CONTACT', 'email': 'mariannaadamo@hotmail.com', 'phone': '+390303995564'}, {'name': 'Paolo Denti', 'role': 'CONTACT', 'email': 'paolodenti@hotmail.com'}, {'name': 'Marianna Adamo', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paolo Denti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marianna Adamo', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'centralContacts': [{'name': 'Marianna Adamo', 'role': 'CONTACT', 'email': 'mariannaadamo@hotmail.com', 'phone': '+390303995564'}, {'name': 'Paolo Denti', 'role': 'CONTACT', 'email': 'paolodenti@hotmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marianna Adamo', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Raffaele University Hospital, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marianna Adamo', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}}}}