Back to resultsThe Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
Primary Purpose
Functional Tricuspid Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pivot Bridge
Sponsored by
About this trial
This is an interventional treatment trial for Functional Tricuspid Regurgitation focused on measuring FTR, RV failure, TauPnu
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
Sites / Locations
- Keimyung University Dongsan HospitalRecruiting
- Hallym University Medical CenterRecruiting
- Sejong HOSPITALRecruiting
- Pusan National University Yangsan HospitalRecruiting
- Chungnam National University Hospital (CNU Hospital)Recruiting
- Chungnam National University sejong HospitalRecruiting
- Ulsan HospitalRecruiting
- Asan Medical CenterRecruiting
- Bucheon Sejong HospitalRecruiting
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pivot Bridge
Arm Description
transcatheter for short-term treat Functional Tricuspid regurgitation
Outcomes
Primary Outcome Measures
Assessment of Acute phase safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Secondary Outcome Measures
Efficacy endpoint-1: Changes of hemodynamics
Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Efficacy endpoint-1: Changes of hemodynamics(1)
Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min
Efficacy endpoint-1: Changes of hemodynamics(2)
Echocardiogram: Fractional area change in percentage
Efficacy endpoint-1: Changes of hemodynamics(3)
Echocardiogram: LVEF in percentage
Efficacy endpoint-1: Changes of hemodynamics(4)
Echocardiogram: Peak systolic annular velocity in cm/sec
Efficacy endpoint-1: Changes of hemodynamics(5)
Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Efficacy endpoint-1: Changes of hemodynamics(6)
Echocardiogram: LVOT stroke volume in ml
Efficacy endpoint-1: Changes of hemodynamics(7)
Echocardiogram: TV annular diameter in mm
Efficacy endpoint-1: Changes of hemodynamics(8)
Echocardiogram: RV diameter base in mm
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
Efficacy endpoint-1: Changes of hemodynamics(10)
Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Efficacy endpoint-1: Changes of hemodynamics(11)
Cardiac CT : RV volume in ml
Efficacy endpoint-2: Technical feasibility and TR grade changes
Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters
Assessment of short-term safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Full Information
NCT ID
NCT05854095
First Posted
January 30, 2023
Last Updated
May 2, 2023
Sponsor
Tau Pnu Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05854095
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tau Pnu Medical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Tricuspid Regurgitation
Keywords
FTR, RV failure, TauPnu
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pivot Bridge
Arm Type
Experimental
Arm Description
transcatheter for short-term treat Functional Tricuspid regurgitation
Intervention Type
Device
Intervention Name(s)
Pivot Bridge
Intervention Description
transcatheter for short-term treat Functional Tricuspid regurgitation
Primary Outcome Measure Information:
Title
Assessment of Acute phase safety
Description
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time Frame
immediately after the procedure
Secondary Outcome Measure Information:
Title
Efficacy endpoint-1: Changes of hemodynamics
Description
Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(1)
Description
Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(2)
Description
Echocardiogram: Fractional area change in percentage
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(3)
Description
Echocardiogram: LVEF in percentage
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(4)
Description
Echocardiogram: Peak systolic annular velocity in cm/sec
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(5)
Description
Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(6)
Description
Echocardiogram: LVOT stroke volume in ml
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(7)
Description
Echocardiogram: TV annular diameter in mm
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(8)
Description
Echocardiogram: RV diameter base in mm
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(9)
Description
Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(10)
Description
Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Time Frame
within 1week of implant
Title
Efficacy endpoint-1: Changes of hemodynamics(11)
Description
Cardiac CT : RV volume in ml
Time Frame
within 1week of implant
Title
Efficacy endpoint-2: Technical feasibility and TR grade changes
Description
Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters
Time Frame
within 1week of implant
Title
Assessment of short-term safety
Description
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time Frame
within 1week of implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Yong Hahn, PhD
Phone
+82553678783
Email
jyhahn@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
June-Hong Kim, PhD
Phone
+82553678783
Email
junehongk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Dalseo-gu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyeokJoon Yoon
Phone
+82-53-250-7314
First Name & Middle Initial & Last Name & Degree
Cheol-Hyun Lee
First Name & Middle Initial & Last Name & Degree
In-Cheol Kim
First Name & Middle Initial & Last Name & Degree
Hyeok-Joon Yoon
Facility Name
Hallym University Medical Center
City
Anyang
State/Province
Dongan-gu
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Suk Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hyun-Suk Kim
First Name & Middle Initial & Last Name & Degree
Youn-suck Koh
First Name & Middle Initial & Last Name & Degree
Sung-Ai Kim
First Name & Middle Initial & Last Name & Degree
Sang-Jin Han
First Name & Middle Initial & Last Name & Degree
Ji Yeon Hong
Facility Name
Sejong HOSPITAL
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14754
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi
Phone
+82-1599-6677
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi
First Name & Middle Initial & Last Name & Degree
Ha-Uk Park
First Name & Middle Initial & Last Name & Degree
Chi-Hoon Kim
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50602
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Hyun Park, MD, PhD
Phone
+82-55-360-1594
Email
nadroj@chol.com
First Name & Middle Initial & Last Name & Degree
June-Hong Kim, MD, PhD
Phone
+82-55-360-1458
Email
junehongk@gmail.com
First Name & Middle Initial & Last Name & Degree
Min-Ku Chon, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ki-Won Hwang, MD
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeong-Su Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Soo-Yong Lee, MD
First Name & Middle Initial & Last Name & Degree
Hyung-Gon Je, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ki-Seok Choo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yong-Hyun Park
Facility Name
Chungnam National University Hospital (CNU Hospital)
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD, PhD
Phone
+82-42-280-7795
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park
Facility Name
Chungnam National University sejong Hospital
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hwan Lee, MD, PhD
Phone
+82-42-280-7795
First Name & Middle Initial & Last Name & Degree
Jae-Hyung Roh
First Name & Middle Initial & Last Name & Degree
Yong-Hun Yun
Facility Name
Ulsan Hospital
City
Ulsan
State/Province
Nam-gu
ZIP/Postal Code
44686
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin
Phone
+82-52-259-5000
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin, MD,PhD
First Name & Middle Initial & Last Name & Degree
Gwansic Kim, MD,PhD
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-whan Lee, MD, PhD
Phone
+82-2-3010-3170
First Name & Middle Initial & Last Name & Degree
Tae-Oh Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dae-Hee Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seung-whan Lee, MD, PhD
Facility Name
Bucheon Sejong Hospital
City
Bucheon-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeong-Jin Choi, MD,PhD
First Name & Middle Initial & Last Name & Degree
Yeong-Jin Choi, MD,PhD
First Name & Middle Initial & Last Name & Degree
Chi-Hoon Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Ha-Wook Park, MD,PhD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD,PhD
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD,PhD
First Name & Middle Initial & Last Name & Degree
Eun-Gyeong Kim, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
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