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

Functional Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854095
• Other study ID #: Pivot Bridge-FIM
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: February 2024
• Source: Tau Pnu Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 27, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Pivot Bridge
transcatheter for short-term treat Functional Tricuspid regurgitation

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Dongan-gu
Korea, Republic of	Bucheon Sejong Hospital	Bucheon-si
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Dalseo-gu
Korea, Republic of	Chungnam National University Hospital (CNU Hospital)	Daejeon	Jung-gu
Korea, Republic of	Chungnam National University sejong Hospital	Daejeon	Jung-gu
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Ulsan Hospital	Ulsan	Nam-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Acute phase safety	Check all adverse reactions Including serious adverse events and serious adverse medical device reactions	immediately after the procedure
Secondary	Efficacy endpoint-1: Changes of hemodynamics	Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml	within 1week of implant
Secondary	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
Secondary	Efficacy endpoint-1: Changes of hemodynamics(2)	Echocardiogram: Fractional area change in percentage	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(3)	Echocardiogram: LVEF in percentage	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(4)	Echocardiogram: Peak systolic annular velocity in cm/sec	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(5)	Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(6)	Echocardiogram: LVOT stroke volume in ml	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(7)	Echocardiogram: TV annular diameter in mm	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(8)	Echocardiogram: RV diameter base in mm	within 1week of implant
Secondary	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
Secondary	Efficacy endpoint-1: Changes of hemodynamics(10)	Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio	within 1week of implant
Secondary	Efficacy endpoint-1: Changes of hemodynamics(11)	Cardiac CT : RV volume in ml	within 1week of implant
Secondary	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
Secondary	Assessment of short-term safety	Check all adverse reactions Including serious adverse events and serious adverse medical device reactions	within 1week of implant