[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06954792":3,"trial-entities:NCT06954792":90,"trial-summary:NCT06954792":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":36,"sex":61,"minimum_age":62,"maximum_age":25,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT06954792","AAAV0931","Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study","Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement","ENROLLING_BY_INVITATION","2029-05-01","2026-02","2026-02-12","2027-01","Columbia University","OTHER",false,"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).","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.",[19,20,21,22],"Tricuspid Regurgitation","Heart Failure","Structural Heart Disease","Interventional Cardiology",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},140,"ESTIMATED",[],[32],{"measure":33,"description":34,"timeFrame":35},"Mortality Rate","The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.","1 Year",[37,41,44,47,50,54,57],{"measure":38,"description":39,"timeFrame":40},"Number of Participants with Coronary Artery Disease (CAD)","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.","Baseline (Day 0)",{"measure":42,"description":43,"timeFrame":40},"Number of Participants with Right Ventricular (RV) Dysfunction","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":45,"description":46,"timeFrame":40},"Number of Participants with Pulmonary Hypertension","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":48,"description":49,"timeFrame":40},"Number of Participants with Primary Left Ventricular Cardiomyopathy","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":51,"description":52,"timeFrame":53},"Number of Participants with Post-Procedural Fever","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.","Within 48 hours after the procedure",{"measure":55,"description":56,"timeFrame":53},"Number of Participants with Post-procedural Inflammatory Response","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":58,"description":59,"timeFrame":60},"Number of Participants with AHI","Number of Participants with AHI among all the population screened","Within 24 hours after the procedure","ALL","18 Years",{"inclusion":64,"exclusion":67,"raw_text":70},[65,66],"Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And","Patients presenting an AHI, defined by the need for inotrope and\u002For vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).",[68,69],"Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )","Patients started on inotrope\u002Fvasopressor either as part of a routine post-interventional protocol or preventively for \"right ventricular (RV) support\" without sign of hypoperfusion.","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\u002For 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\u002Fvasopressor either as part of a routine post-interventional protocol or preventively for \"right ventricular (RV) support\" without sign of hypoperfusion.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":77,"zip":78,"country":79,"geoPoint":80},"Columbia University Medical Center","New York","10032","United States",{"lat":81,"lon":82},40.71427,-74.00597,[],[85],{"name":86,"affiliation":13,"role":87},"Tamim Nazif, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[20,21,92],"Tricuspid Valve Insufficiency",[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]