Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT03416166
Status:
RECRUITING
Last Update Posted:
2018-01-30
First Post:
2018-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Multisite Transcatheter Tricuspid Valve Therapies Registry
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 269}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Death', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'NYHA Class', 'timeFrame': '30 days, 1 year'}, {'measure': 'TR Reduction', 'timeFrame': '30 days, 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tricuspid Valve', 'tricuspid regurgitation', 'transcatheter tricuspid regurgitation'], 'conditions': ['Severe Tricuspid Regurgitation']}, 'referencesModule': {'references': [{'pmid': '36445158', 'type': 'DERIVED', 'citation': 'Scotti A, Coisne A, Taramasso M, Granada JF, Ludwig S, Rodes-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Rosiene J, Feinberg A, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estevez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntane-Carol G, Gavazzoni M, Braun D, Koell B, Kalbacher D, Connelly KA, Juliard JM, Harr C, Pedrazzini G, Russo G, Philippon F, Schofer J, Thiele H, Unterhuber M, Himbert D, Alcazar MU, Wild MG, Windecker S, Jorde U, Maisano F, Leon MB, Hahn RT, Latib A. Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation. Eur Heart J. 2023 Mar 7;44(10):822-832. doi: 10.1093/eurheartj/ehac735.'}, {'pmid': '33541097', 'type': 'DERIVED', 'citation': 'Muntane-Carol G, Taramasso M, Miura M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schafer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, Rodes-Cabau J. Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry. Circ Cardiovasc Interv. 2021 Feb;14(2):e009685. doi: 10.1161/CIRCINTERVENTIONS.120.009685. Epub 2021 Feb 5.'}, {'pmid': '32912460', 'type': 'DERIVED', 'citation': 'Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, Biasco L, Lurz P, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Loureiro R, Fam N, Frerker C, Gavazzoni M, Hausleiter J, Himbert D, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntane-Carol G, Nazif T, Nickenig G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Thiele H, Rommel KP, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Maisano F, Hahn RT, Taramasso M; TriValve Investigators. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1999-2009. doi: 10.1016/j.jcin.2020.05.011.'}]}, 'descriptionModule': {'briefSummary': 'For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).\n\nTranscatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.\n\nThe main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe symptomatic tricuspid regurgitation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients undergoing transcatheter tricuspid valve intervention.\n\nGeneral inclusion criteria:\n\n* Minimal age: 18 years\n* Patient is able to give written informed consent to the procedure\n\nExclusion Criteria:\n\n* Patients not fulfilling the indications for transcatheter tricuspid intervention'}, 'identificationModule': {'nctId': 'NCT03416166', 'acronym': 'TriValve', 'briefTitle': 'International Multisite Transcatheter Tricuspid Valve Therapies Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'International Multisite Transcatheter Tricuspid Valve Therapies Registry', 'orgStudyIdInfo': {'id': '2016-01753'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter Tricuspid Intervention', 'type': 'DEVICE', 'description': 'Any available transcatheter tricuspid valve intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Maurizio Taramasso, MD, PhD', 'role': 'CONTACT', 'email': 'maurizio.taramasso@usz.ch', 'phone': '0041442553728'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Maurizio Taramasso, MD, PhD', 'role': 'CONTACT', 'email': 'maurizio.taramasso@usz.ch', 'phone': '0041442553728'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}