Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT05854095
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Acute phase safety', 'timeFrame': 'immediately after the procedure', 'description': 'Check all adverse reactions Including serious adverse events and serious adverse medical device reactions'}], 'secondaryOutcomes': [{'measure': 'Efficacy endpoint-1: Changes of hemodynamics', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(1)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(2)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: Fractional area change in percentage'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(3)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: LVEF in percentage'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(4)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: Peak systolic annular velocity in cm/sec'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(5)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(6)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: LVOT stroke volume in ml'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(7)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: TV annular diameter in mm'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(8)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: RV diameter base in mm'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(9)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(10)', 'timeFrame': 'within 1week of implant', 'description': 'Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio'}, {'measure': 'Efficacy endpoint-1: Changes of hemodynamics(11)', 'timeFrame': 'within 1week of implant', 'description': 'Cardiac CT : RV volume in ml'}, {'measure': 'Efficacy endpoint-2: Technical feasibility and TR grade changes', 'timeFrame': 'within 1week of implant', 'description': 'Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters'}, {'measure': 'Assessment of short-term safety', 'timeFrame': 'within 1week of implant', 'description': 'Check all adverse reactions Including serious adverse events and serious adverse medical device reactions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FTR', 'RV failure', 'TauPnu'], 'conditions': ['Functional Tricuspid Regurgitation']}, 'referencesModule': {'references': [{'pmid': '23667187', 'type': 'BACKGROUND', 'citation': 'Chaabane C, Otsuka F, Virmani R, Bochaton-Piallat ML. Biological responses in stented arteries. Cardiovasc Res. 2013 Jul 15;99(2):353-63. doi: 10.1093/cvr/cvt115. Epub 2013 May 10.'}, {'pmid': '24917649', 'type': 'BACKGROUND', 'citation': 'Hwang HY, Kim KH, Kim KB, Ahn H. Treatment for severe functional tricuspid regurgitation: annuloplasty versus valve replacement. Eur J Cardiothorac Surg. 2014 Aug;46(2):e21-7. doi: 10.1093/ejcts/ezu224. Epub 2014 Jun 10.'}, {'pmid': '1747281', 'type': 'BACKGROUND', 'citation': 'Groves PH, Lewis NP, Ikram S, Maire R, Hall RJ. Reduced exercise capacity in patients with tricuspid regurgitation after successful mitral valve replacement for rheumatic mitral valve disease. Br Heart J. 1991 Oct;66(4):295-301. doi: 10.1136/hrt.66.4.295.'}, {'pmid': '31326430', 'type': 'BACKGROUND', 'citation': 'Rommel KP, Besler C, Noack T, Blazek S, von Roeder M, Fengler K, Ender J, Gutberlet M, Desch S, Borger MA, Thiele H, Lurz P. Physiological and Clinical Consequences of Right Ventricular Volume Overload Reduction After Transcatheter Treatment for Tricuspid Regurgitation. JACC Cardiovasc Interv. 2019 Aug 12;12(15):1423-1434. doi: 10.1016/j.jcin.2019.02.042. Epub 2019 Jul 17.'}, {'pmid': '29246545', 'type': 'BACKGROUND', 'citation': 'Kelly BJ, Ho Luxford JM, Butler CG, Huang CC, Wilusz K, Ejiofor JI, Rawn JD, Fox JA, Shernan SK, Muehlschlegel JD. Severity of tricuspid regurgitation is associated with long-term mortality. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1032-1038.e2. doi: 10.1016/j.jtcvs.2017.09.141. Epub 2017 Nov 8.'}, {'pmid': '31568868', 'type': 'BACKGROUND', 'citation': 'Taramasso M, Benfari G, van der Bijl P, Alessandrini H, 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, 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, Nickening G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Thiele H, Topilsky Y, Rommel KP, Delgado V, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Hahn RT, Bax JJ, Enriquez-Sarano M, Maisano F. Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Dec 17;74(24):2998-3008. doi: 10.1016/j.jacc.2019.09.028. Epub 2019 Sep 27.'}, {'pmid': '32175231', 'type': 'BACKGROUND', 'citation': 'Kolte D, Elmariah S. Current state of transcatheter tricuspid valve repair. Cardiovasc Diagn Ther. 2020 Feb;10(1):89-97. doi: 10.21037/cdt.2019.09.11.'}, {'pmid': '31787551', 'type': 'BACKGROUND', 'citation': 'Izumi C. Isolated functional tricuspid regurgitation: When should we go to surgical treatment? J Cardiol. 2020 Apr;75(4):339-343. doi: 10.1016/j.jjcc.2019.11.001. Epub 2019 Nov 29.'}, {'pmid': '35291509', 'type': 'BACKGROUND', 'citation': 'Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022 Feb 15;12(1):1-18. eCollection 2022.'}, {'pmid': '29929618', 'type': 'BACKGROUND', 'citation': 'Asmarats L, Puri R, Latib A, Navia JL, Rodes-Cabau J. Transcatheter Tricuspid Valve Interventions: Landscape, Challenges, and Future Directions. J Am Coll Cardiol. 2018 Jun 26;71(25):2935-2956. doi: 10.1016/j.jacc.2018.04.031.'}, {'pmid': '28982563', 'type': 'BACKGROUND', 'citation': 'Taramasso M, Hahn RT, Alessandrini H, Latib A, Attinger-Toller A, Braun D, Brochet E, Connelly KA, Denti P, Deuschl F, Englmaier A, Fam N, Frerker C, Hausleiter J, Juliard JM, Kaple R, Kreidel F, Kuck KH, Kuwata S, Ancona M, Malasa M, Nazif T, Nickenig G, Nietlispach F, Pozzoli A, Schafer U, Schofer J, Schueler R, Tang G, Vahanian A, Webb JG, Yzeiraj E, Maisano F, Leon MB. The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair? JACC Cardiovasc Interv. 2017 Oct 9;10(19):1982-1990. doi: 10.1016/j.jcin.2017.08.011.'}, {'pmid': '31178930', 'type': 'BACKGROUND', 'citation': 'Curio J, Demir OM, Pagnesi M, Mangieri A, Giannini F, Weisz G, Latib A. Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment. Interv Cardiol. 2019 May 21;14(2):54-61. doi: 10.15420/icr.2019.5.1. eCollection 2019 May.'}, {'pmid': '33139325', 'type': 'BACKGROUND', 'citation': 'Park SJ, Oh JK, Kim SO, Lee SA, Kim HJ, Lee S, Jung SH, Song JM, Choo SJ, Kang DH, Chung CH, Song JK, Lee JW, Kim DH, Kim JB. Determinants of clinical outcomes of surgery for isolated severe tricuspid regurgitation. Heart. 2021 Mar;107(5):403-410. doi: 10.1136/heartjnl-2020-317715. Epub 2020 Nov 2.'}, {'pmid': '28385308', 'type': 'BACKGROUND', 'citation': 'Hahn RT, Meduri CU, Davidson CJ, Lim S, Nazif TM, Ricciardi MJ, Rajagopal V, Ailawadi G, Vannan MA, Thomas JD, Fowler D, Rich S, Martin R, Ong G, Groothuis A, Kodali S. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.'}]}, 'descriptionModule': {'briefSummary': "evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation", 'detailedDescription': "evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult males and females aged 20 years or above\n* Patients with clinical symptoms (Symptomatic) whose degree of tricuspid regurgitation using echocardiography meets the criteria of Severe or higher presented in the TR grade classification table\n* Short-term treatment using a catheter is required (expected to be effective) by a local site heart team including at least one cardiothoracic (cardiovascular) specialist and at least one thoracic surgeon each, and clinical symptoms of NYHA Class Ⅱ or higher person who falls under\n* In the screening test, A person who can confirm the possibility of reducing tricuspid valve regurgitation by inserting that 'Pivot Balloon' (Clinical Trial Approval No. 1327), etc.) through the same access path as the 'Pivot Bridge', a clinical trial medical device\n* An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent\n* An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial\n\nExclusion Criteria:\n\n* Uncontrolled hyperthyroidism\n* A recent formation of soft blood clot or embolic material\n* Uncorrected coagulopathy\n* Prohibition of anticoagulant agents\n* Those who had experience with anticoagulant use prior to participation in this clinical trial and who were treated with major bleeding (minor bleeding such as nosebleeds that can be hemostasis not applicable) due to anticoagulant use at this time or accompanied by severe anemia requiring hospitalization one with experience\n* Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker\n* Those who is judged to have little possibility of reducing tricuspid valve regurgitation by inserting a balloon-type device (e.g. ASD sizing balloon, pivot balloon, etc.) through the same access route as the clinical trial medical device 'Pivot Bridge'\n* Persons with an anatomical structure that cannot be inserted through the corresponding route"}, 'identificationModule': {'nctId': 'NCT05854095', 'briefTitle': "The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR", 'organization': {'class': 'INDUSTRY', 'fullName': 'Tau-MEDICAL Co., Ltd.'}, 'officialTitle': "The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study", 'orgStudyIdInfo': {'id': 'Pivot Bridge-FIM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pivot Bridge', 'description': 'transcatheter for short-term treat Functional Tricuspid regurgitation', 'interventionNames': ['Device: Pivot Bridge']}], 'interventions': [{'name': 'Pivot Bridge', 'type': 'DEVICE', 'description': 'transcatheter for short-term treat Functional Tricuspid regurgitation', 'armGroupLabels': ['Pivot Bridge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42601', 'city': 'Daegu', 'state': 'Dalseo-gu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '14068', 'city': 'Anyang', 'state': 'Dongan-gu', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '14754', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '50602', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '35015', 'city': 'Daejeon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital (CNU Hospital)', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35015', 'city': 'Daejeon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Chungnam National University sejong Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '44686', 'city': 'Ulsan', 'state': 'Nam-gu', 'country': 'South Korea', 'facility': 'Ulsan Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Bucheon Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joo-Yong Hahn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tau-MEDICAL Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joo Yong Hahn', 'investigatorAffiliation': 'Samsung Medical Center'}}}}