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

NCT05854095 | Completed

• 1 other identifier: Pivot Bridge-FIM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Functional Tricuspid Regurgitation

Keywords

FTR; RV failure; TauPnu

Outcome Measures

Primary Outcomes (1)

• Assessment of Acute phase safety

  Check all adverse reactions Including serious adverse events and serious adverse medical device reactions

  immediately after the procedure

Secondary Outcomes (14)

• Efficacy endpoint-1: Changes of hemodynamics

  within 1week of implant

• Efficacy endpoint-1: Changes of hemodynamics(1)

  within 1week of implant

• Efficacy endpoint-1: Changes of hemodynamics(2)

  within 1week of implant

• Efficacy endpoint-1: Changes of hemodynamics(3)

  within 1week of implant

• Efficacy endpoint-1: Changes of hemodynamics(4)

  within 1week of implant

Study Arms (1)

Pivot Bridge

EXPERIMENTAL

transcatheter for short-term treat Functional Tricuspid regurgitation

Device: Pivot Bridge

Interventions

Pivot Bridge DEVICE

transcatheter for short-term treat Functional Tricuspid regurgitation

Pivot Bridge

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (10)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Hallym University Medical Center

Anyang, Dongan-gu, 14068, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50602, South Korea

Location

Chungnam National University Hospital (CNU Hospital)

Daejeon, Jung-gu, 35015, South Korea

Location

Chungnam National University sejong Hospital

Daejeon, Jung-gu, 35015, South Korea

Location

Ulsan Hospital

Ulsan, Nam-gu, 44686, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Bucheon Sejong Hospital

Bucheon-si, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (14)

• 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: 23667187 BACKGROUND

• 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: 24917649 BACKGROUND

• 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: 1747281 BACKGROUND

• 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: 31326430 BACKGROUND

• 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: 29246545 BACKGROUND

• 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: 31568868 BACKGROUND

• 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: 32175231 BACKGROUND

• 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: 31787551 BACKGROUND

• Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022 Feb 15;12(1):1-18. eCollection 2022.

  PMID: 35291509 BACKGROUND

• 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: 29929618 BACKGROUND

• 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: 28982563 BACKGROUND

• 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: 31178930 BACKGROUND

• 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: 33139325 BACKGROUND

• 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.

  PMID: 28385308 BACKGROUND

Study Officials

• Joo-Yong Hahn, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: May 11, 2023
• Study Start: March 13, 2023
• Primary Completion: October 17, 2023
• Study Completion: December 27, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

KR (10)