Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 5:10 PM
Study NCT ID:
NCT06954792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-12
First Post:
2025-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '1 Year', 'description': 'The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Coronary Artery Disease (CAD)', 'timeFrame': 'Baseline (Day 0)', 'description': 'Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.\n\nThe number of participants with CAD will be reported.'}, {'measure': 'Number of Participants with Right Ventricular (RV) Dysfunction', 'timeFrame': 'Baseline (Day 0)', 'description': 'Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.\n\nThe number of participants with RV dysfunction will be reported.'}, {'measure': 'Number of Participants with Pulmonary Hypertension', 'timeFrame': 'Baseline (Day 0)', 'description': 'Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with pulmonary hypertension will be reported.'}, {'measure': 'Number of Participants with Primary Left Ventricular Cardiomyopathy', 'timeFrame': 'Baseline (Day 0)', 'description': 'Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with primary left ventricular cardiomyopathy will be reported.'}, {'measure': 'Number of Participants with Post-Procedural Fever', 'timeFrame': 'Within 48 hours after the procedure', 'description': 'The number of participants with post-procedural fever will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.'}, {'measure': 'Number of Participants with Post-procedural Inflammatory Response', 'timeFrame': 'Within 48 hours after the procedure', 'description': 'The number of participants with post-procedural inflammatory response will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.'}, {'measure': 'Number of Participants with AHI', 'timeFrame': 'Within 24 hours after the procedure', 'description': 'Number of Participants with AHI among all the population screened'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Regurgitation', 'Heart Failure', 'Structural Heart Disease', 'Interventional Cardiology']}, 'descriptionModule': {'briefSummary': 'TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).', 'detailedDescription': 'TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population represents TTVR patients presenting specifically an AHI after their intervention. In turn, the control group includes an all-comer population undergoing TTVR.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And\n* Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator\'s judgement).\n\nExclusion Criteria:\n\n* Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )\n* Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.'}, 'identificationModule': {'nctId': 'NCT06954792', 'acronym': 'TTVR-AHI', 'briefTitle': 'Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement', 'orgStudyIdInfo': {'id': 'AAAV0931'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No AHI', 'description': 'Patients undergoing TTVR without presenting any AHI post-procedurally'}, {'label': 'AHI', 'description': 'Patients undergoing TTVR and presenting AHI within 24h after the procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tamim Nazif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}