Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-25 @ 10:56 AM
Study NCT ID:
NCT04634266
Status:
RECRUITING
Last Update Posted:
2022-08-23
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRICuspid Intervention in Heart Failure Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, controlled, multicenter, randomized, open label trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of transcatheter tricuspid valve intervention', 'timeFrame': '1 month', 'description': 'Major adverse events that are related to the intervention and are relevant for patients undergoing TTVT: Mortality, life threatening bleeding (defined as BARC bleeding type 3 and 5), major vascular or cardiac structural complications requiring intervention, or mechanical circulatory support.'}], 'primaryOutcomes': [{'measure': 'All-cause mortality or heart failure hospitalization', 'timeFrame': '12 months', 'description': 'Composite of time to all-cause mortality or heart failure hospitalization - whichever occurs first - at a minimum follow-up of 12 months'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality (unadjusted and adjusted for TR severity at baseline)', 'timeFrame': '12 months'}, {'measure': 'Heart failure hospitalizations (frequency and length; unadjusted and adjusted for TR severity at baseline)', 'timeFrame': '12 months'}, {'measure': 'Change in Quality of Life as assessed by the MLHFQ from baseline', 'timeFrame': '12 months'}, {'measure': 'Re-intervention rates for recurrent tricuspid regurgitation', 'timeFrame': '12 months'}, {'measure': 'Change in NYHA Class from baseline (≥III/IV to ≤I/II)', 'timeFrame': '12 months'}, {'measure': 'Change in 6 minute walk test distance from baseline', 'timeFrame': '12 months'}, {'measure': 'Change in echocardiographic parameters (among others: TR grade I-V, RV dimension and function, LV dimension and function, estimation of sPAP)', 'timeFrame': '12 months'}, {'measure': 'Development of tricuspid stenosis (mean inflow gradient >5mmHg)', 'timeFrame': '12 months'}, {'measure': 'Change in peripheral edema assessed by the edema scale (grade I-IV) and subject weight (kilograms) from baseline', 'timeFrame': '12 months'}, {'measure': 'Change of diuretic drugs and heart failure medications from baseline (type and dosage)', 'timeFrame': '12 months'}, {'measure': 'Change in laboratory markers for cardiac, renal and hepatic function (complete blood count, NT-proBNP, eGFR, serum creatinine, bilirubin, AST, ALT and gGT)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure Attributable to Severe Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': 'Functional tricuspid regurgitation (TR) is a serious and progressive disease. Guidelines recommend surgical valve repair of severe TR in symptomatic patients. Despite its association with excess mortality and morbidity, TR has been relatively neglected and is severely undertreated. In particular this is because isolated tricuspid surgery remains associated with high mortality rates, and thus, patients with severe TR are often deemed inoperable due to severe co-morbidities and frailty. In recent years, percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT) have emerged as alternatives to surgery. These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL). Several non-randomized studies suggested improved functional outcomes after TTVT, however, to data there is no evidence from randomized controlled trials addressing the actual efficacy of TTVT. The TRICuspid Intervention in Heart Failure trial (TRICI-HF trial) will assess the concept that TTVT will translate into a reduced morbidity and mortality. Patients will be randomly assigned in a 2:1 fashion to TTVT plus OMT (Experimental group) or OMT alone (Control group). TRICI-HF is an industry-independent, investigator-initiated strategy study and investigators may choose any suitable CE-marked percutaneous system "on-label" for TTVT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The following inclusion criteria were defined to assure generalizability of the population to be studied:\n\n* Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team. Patients with reduced left ventricular ejection fraction (HFrEF) will likely constitute a minority among eligible patients with isolated severe tricuspid regurgitation (9,13). However, HFrEF patients enrolled into the trial need to be on stable guideline-directed medical therapy for at least 4 weeks..\n* Subject is at intermediate or greater estimated risk of mortality with tricuspid valve surgery based on judgment of the local heart team\n* New York Heart Association (NYHA) Functional Class II, III or IVa\n* Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging)\n* Age ≥ 18 years at time of consent\n* Subject must provide written informed consent prior to any trial related procedure\n\nThe following exclusion criteria were selected to define a representative study cohort:\n\n* Presence of severe aortic, mitral or pulmonary valve disease OR surgical/interventional treatment at the aortic, mitral or pulmonary valves prior 60 days\n* Right heart catheterization (mandatory) with systolic pulmonary artery pressure \\> 70 mmHg or substantial pre-capillary pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) \\>30 mmHg plus transpulmonary gradient (TPG) \\>17 mmHg or pulmonary vascular resistance (PVR) \\>5 wood units)\n* Tricuspid valve stenosis (tricuspid mean gradient \\> 5 mmHg)\n* Pacemaker or ICD leads that would prevent appropriate TTVT\n* Prior tricuspid valve procedures or tricuspid valve leaflet anatomy that would interfere with appropriate TTVT (e.g. calcification, Ebstein anomaly, coaptation defect \\> 8mm for planned leaflet- and annuloplasty-based therapy)\n* Chronic renal failure requiring dialysis\n* Tricuspid valve anatomy not evaluable by TTE and TEE\n* Myocardial infarction or cerebrovascular accident within prior 90 days\n* Life expectancy of less than 12 months'}, 'identificationModule': {'nctId': 'NCT04634266', 'acronym': 'TRICI-HF', 'briefTitle': 'TRICuspid Intervention in Heart Failure Trial', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)', 'orgStudyIdInfo': {'id': 'TRICI-HF'}, 'secondaryIdInfos': [{'id': 'TRICI-HF-DZHK24', 'type': 'OTHER_GRANT', 'domain': 'Deutsches Zentrum für Herzkreislaufforschung'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental intervention', 'description': 'Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)', 'interventionNames': ['Device: Transcatheter tricuspid valve treatment (TTVT)']}, {'type': 'NO_INTERVENTION', 'label': 'Control intervention', 'description': 'OMT for severe tricuspid regurgitation in right-sided heart failure'}], 'interventions': [{'name': 'Transcatheter tricuspid valve treatment (TTVT)', 'type': 'DEVICE', 'description': 'Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).', 'armGroupLabels': ['Experimental intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Krozingen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Comberg', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Bad Oeynhausen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volker Rudolph', 'role': 'CONTACT'}], 'facility': 'Herz- und Diabeteszentrum Nordrhein-Westfalen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Bad Rothenfelde', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marek Kowalski', 'role': 'CONTACT'}], 'facility': 'Schüchtermann-Klinik', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulf Landmesser', 'role': 'CONTACT'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volkmar Falk', 'role': 'CONTACT'}], 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Nickenig', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Baldus', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dortmund', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Helge Möllmann', 'role': 'CONTACT'}], 'facility': 'St.-Johannes-Hospital Dortmund', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Erfurt', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Lauten', 'role': 'CONTACT'}], 'facility': 'Helios Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tienush Rassaf', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Zeiher', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Bode', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Giessen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Holger Nef', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Göttingen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claudius Jacobshagen', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Niklas Schofer, MD', 'role': 'CONTACT', 'email': 'n.schofer@uke.de'}], 'facility': 'Herzzentrum UKE', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Elke Lubos, MD', 'role': 'CONTACT', 'email': 'e.lubos@marienkrankenhaus.org'}], 'facility': 'Katholisches Marienkrankenhaus Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim Schofer', 'role': 'CONTACT'}], 'facility': 'MVZ Prof. Mathey/Schofer', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Jena', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Schulze', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Derk Frank', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leipzig', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Lurz', 'role': 'CONTACT'}], 'facility': 'Herzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan von Bardeleben', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joerg Hausleiter, MD', 'role': 'CONTACT'}, {'name': 'Joerg Hausleiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Stocker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Braun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Steffen Massberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LMU Klinikum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Siegburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Boekstegers', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Siegburg', 'geoPoint': {'lat': 50.80019, 'lon': 7.20769}}], 'centralContacts': [{'name': 'Joerg Hausleiter, MD', 'role': 'CONTACT', 'email': 'joerg.hausleiter@med.uni-muenchen.de', 'phone': '+4989440072361'}, {'name': 'Thomas Stocker, MD', 'role': 'CONTACT', 'email': 'thomas.stocker@med.uni-muenchen.de', 'phone': '+49894400712625'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Diabetes Center North Rhine-Westphalia', 'class': 'OTHER'}, {'name': 'University Medical Center Mainz', 'class': 'OTHER'}, {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, {'name': 'Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)', 'class': 'OTHER'}, {'name': 'University of Leipzig', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thomas Stocker', 'investigatorAffiliation': 'LMU Klinikum'}}}}