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

Study Overview
=================
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

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

Conditions
-----------------
Functional Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Device: Pivot Bridge


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivot Bridge<br>transcatheter for short-term treat Functional Tricuspid regurgitation | Device: Pivot Bridge<br>* transcatheter for short-term treat Functional Tricuspid regurgitation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Acute phase safety | Check all adverse reactions Including serious adverse events and serious adverse medical device reactions | immediately after the procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FTR, RV failure, TauPnu