Clinical trial NCT05854095: The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Tricuspid Regurgitation
Keywords: FTR
RV failure
TauPnu
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Acute phase safety
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Efficacy endpoint-1: Changes of hemodynamics
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(1)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(2)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(3)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(4)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(5)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(6)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(7)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(8)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(9)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(10)
timeFrame: within 1week of implant
measure: Efficacy endpoint-1: Changes of hemodynamics(11)
timeFrame: within 1week of implant
measure: Efficacy endpoint-2: Technical feasibility and TR grade changes
timeFrame: within 1week of implant
measure: Assessment of short-term safety
timeFrame: within 1week of implant
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Dongan-gu
city: Bucheon-si
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNU Hospital)
state: Jung-gu
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University sejong Hospital
state: Jung-gu
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
state: Nam-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon-si
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joo-Yong Hahn, PhD
role: PRINCIPAL_INVESTIGATOR
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