Functional Tricuspid RegurgitationNCT05854095
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
A study testing Pivot Bridge in people with Functional Tricuspid Regurgitation, run by Tau-MEDICAL Co., Ltd. at 10 sites in South Korea.
Trial summary
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation
- What is being tested?
- Pivot Bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 13 Mar 2023to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Hallym University Medical Center
Anyang, Dongan-gu, 14068
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14754
Bucheon Sejong Hospital
Bucheon-si
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601
Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, 35015
Chungnam National University sejong Hospital
Daejeon, Jung-gu, 35015
Asan Medical Center
Seoul, Songpa-gu, 05505
Samsung Medical Center
Seoul
Ulsan Hospital
Ulsan, Nam-gu, 44686
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50602
About this study
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
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
Read the 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
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- Pivot Bridge
- Keywords
- FTR, RV failure, TauPnu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivot BridgeDevice
transcatheter for short-term treat Functional Tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Pivot Bridge | Experimental | transcatheter for short-term treat Functional Tricuspid regurgitation Receives: Device: Pivot Bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Acute phase safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Measured: immediately after the procedure
Secondary outcomes (14)
Efficacy endpoint-1: Changes of hemodynamics
Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Measured: 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
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(2)
Echocardiogram: Fractional area change in percentage
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(3)
Echocardiogram: LVEF in percentage
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(4)
Echocardiogram: Peak systolic annular velocity in cm/sec
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(5)
Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(6)
Echocardiogram: LVOT stroke volume in ml
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(7)
Echocardiogram: TV annular diameter in mm
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(8)
Echocardiogram: RV diameter base in mm
Measured: 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
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(10)
Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Measured: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(11)
Cardiac CT : RV volume in ml
Measured: 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
Measured: within 1week of implant
Assessment of short-term safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Measured: within 1week of implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start13 Mar 2023
- Primary completion17 Oct 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tau-MEDICAL Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Joo Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854095
- Sponsor's protocol ID
- Pivot Bridge-FIM
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23667187Hwang 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.
PubMed 24917649Groves 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.
PubMed 1747281Rommel 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.
PubMed 31326430Kelly 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.
PubMed 29246545Taramasso 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.
PubMed 31568868Kolte 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.
PubMed 32175231Izumi 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.
PubMed 31787551Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022 Feb 15;12(1):1-18. eCollection 2022.
PubMed 35291509Asmarats 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.
PubMed 29929618Taramasso 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.
PubMed 28982563Curio 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.
PubMed 31178930Park 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.
PubMed 33139325Hahn 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.
PubMed 28385308Kim EK, Chon MK, Kim HS, Park YH, Suh J, Park JH, Lee JH, Choi YJ, Shin ES, Yoon HJ, Yang DH, Park J, Lee SW, Hahn JY. Safety and Efficacy of Pivot-Bridge for Severe Functional Tricuspid Regurgitation: The First-in-Human Experiences. Catheter Cardiovasc Interv. 2026 May;107(6):2069-2077. doi: 10.1002/ccd.70572. Epub 2026 Mar 27.
PubMed 41891323
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05854095
- Acronym / sponsor ID
- Pivot Bridge-FIM
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- FTR, RV failure, TauPnu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tau-MEDICAL Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivot Bridge | Experimental | Device: Pivot Bridgetranscatheter for short-term treat Functional Tricuspid regurgitation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivot Bridgetranscatheter for short-term treat Functional Tricuspid regurgitation | Device | Pivot Bridge |
Primary outcome
Assessment of Acute phase safety
Time frame: immediately after the procedure
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
14 secondary outcomes
Efficacy endpoint-1: Changes of hemodynamics
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(1)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(2)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(3)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(4)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(5)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(6)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(7)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(8)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(9)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(10)
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(11)
Time frame: within 1week of implant
Efficacy endpoint-2: Technical feasibility and TR grade changes
Time frame: within 1week of implant
Assessment of short-term safety
Time frame: within 1week of implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 23667187Chaabane 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.
- Background: PubMed 24917649Hwang 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.
- Background: PubMed 1747281Groves 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.
- Background: PubMed 31326430Rommel 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.
- Background: PubMed 29246545Kelly 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.
- Background: PubMed 31568868Taramasso 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.
- Background: PubMed 32175231Kolte 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.
- Background: PubMed 31787551Izumi 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.
- Background: PubMed 35291509Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022 Feb 15;12(1):1-18. eCollection 2022.
- Background: PubMed 29929618Asmarats 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.
- Background: PubMed 28982563Taramasso 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.
- Background: PubMed 31178930Curio 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Yong Hahn, PhD principal investigator
Samsung Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivot Bridge in people with Functional Tricuspid Regurgitation, run by Tau-MEDICAL Co., Ltd. at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Acute phase safety (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854095, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.