The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR

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

evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation

Study Overview

• Status: Completed
• Conditions: Functional Tricuspid Regurgitation
• Intervention / Treatment: Device: Pivot Bridge

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: June-Hong Kim, PhD; Phone Number: +82553678783; Email: junehongk@gmail.com
• Study Contact Backup: Name: Joo-Yong Hahn, PhD; Phone Number: +82553678783; Email: jyhahn@skku.edu

Study Locations

• Korea, Republic of
  • Bucheon-si, Korea, Republic of
    • Bucheon Sejong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Dalseo-gu
    • Daegu, Dalseo-gu, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital
  • Dongan-gu
    • Anyang, Dongan-gu, Korea, Republic of, 14068
      • Hallym University Medical Center
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14754
      • SoonChunHyang University Bucheon Hospital
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 50602
      • Pusan National University Yangsan Hospital
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Chungnam National University Hospital (CNU Hospital)
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Chungnam National University Sejong Hospital
  • Nam-gu
    • Ulsan, Nam-gu, Korea, Republic of, 44686
      • Ulsan Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult males and females aged 20 years or above
• 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
• 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
• 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
• An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent
• An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial

Exclusion Criteria:

• Uncontrolled hyperthyroidism
• A recent formation of soft blood clot or embolic material
• Uncorrected coagulopathy
• Prohibition of anticoagulant agents
• 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
• Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker
• 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'
• Persons with an anatomical structure that cannot be inserted through the corresponding route

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pivot Bridge; transcatheter for short-term treat Functional Tricuspid regurgitation	Device: Pivot Bridge; transcatheter for short-term treat Functional Tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Acute phase safety	Check all adverse reactions Including serious adverse events and serious adverse medical device reactions	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy endpoint-1: Changes of hemodynamics	Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(1)	Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(2)	Echocardiogram: Fractional area change in percentage	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(3)	Echocardiogram: LVEF in percentage	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(4)	Echocardiogram: Peak systolic annular velocity in cm/sec	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(5)	Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(6)	Echocardiogram: LVOT stroke volume in ml	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(7)	Echocardiogram: TV annular diameter in mm	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(8)	Echocardiogram: RV diameter base in mm	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(9)	Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(10)	Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio	within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(11)	Cardiac CT : RV volume in ml	within 1week of implant
Efficacy endpoint-2: Technical feasibility and TR grade changes	Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters	within 1week of implant
Assessment of short-term safety	Check all adverse reactions Including serious adverse events and serious adverse medical device reactions	within 1week of implant

Collaborators and Investigators

• Sponsor: Tau Pnu Medical Co., Ltd.
• Investigators: Principal Investigator: Joo-Yong Hahn, PhD, Samsung Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022 Feb 15;12(1):1-18. eCollection 2022.
• 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.
• 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.
• 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.
• 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. Erratum In: Heart. 2021 May;107(10):e4.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: TauPnu; FTR; RV failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: Pivot Bridge-FIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No