The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
- Conditions
- Functional Tricuspid Regurgitation
- Interventions
- Device: Pivot Bridge
- Registration Number
- NCT05854095
- Lead Sponsor
- Tau Pnu Medical Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pivot Bridge Pivot Bridge transcatheter for short-term treat Functional Tricuspid regurgitation
- Primary Outcome Measures
Name Time Method Assessment of Acute phase safety immediately after the procedure Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
- Secondary Outcome Measures
Name Time Method Efficacy endpoint-1: Changes of hemodynamics within 1week of implant Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Efficacy endpoint-1: Changes of hemodynamics(1) within 1week of implant Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min
Efficacy endpoint-1: Changes of hemodynamics(2) within 1week of implant Echocardiogram: Fractional area change in percentage
Efficacy endpoint-1: Changes of hemodynamics(3) within 1week of implant Echocardiogram: LVEF in percentage
Efficacy endpoint-1: Changes of hemodynamics(8) within 1week of implant Echocardiogram: RV diameter base in mm
Efficacy endpoint-1: Changes of hemodynamics(10) within 1week of implant Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Efficacy endpoint-1: Changes of hemodynamics(4) within 1week of implant Echocardiogram: Peak systolic annular velocity in cm/sec
Efficacy endpoint-2: Technical feasibility and TR grade changes within 1week of implant Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters
Efficacy endpoint-1: Changes of hemodynamics(5) within 1week of implant Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Efficacy endpoint-1: Changes of hemodynamics(9) within 1week of implant Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal
Efficacy endpoint-1: Changes of hemodynamics(11) within 1week of implant Cardiac CT : RV volume in ml
Efficacy endpoint-1: Changes of hemodynamics(6) within 1week of implant Echocardiogram: LVOT stroke volume in ml
Efficacy endpoint-1: Changes of hemodynamics(7) within 1week of implant Echocardiogram: TV annular diameter in mm
Assessment of short-term safety within 1week of implant Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Trial Locations
- Locations (10)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chungnam National University sejong Hospital
🇰🇷Daejeon, Jung-gu, Korea, Republic of
Bucheon Sejong Hospital
🇰🇷Bucheon-si, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnamdo, Korea, Republic of
Ulsan Hospital
🇰🇷Ulsan, Nam-gu, Korea, Republic of
Chungnam National University Hospital (CNU Hospital)
🇰🇷Daejeon, Jung-gu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Dalseo-gu, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Dongan-gu, Korea, Republic of