Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR

NCT05648838 | Completed

• 1 other identifier: Pivot Balloon-FIM
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 10

Brief Summary

Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Conditions

Functional Tricuspid Regurgitation

Keywords

FTR; RV failure; TauPnu

Outcome Measures

Primary Outcomes (2)

• change of tricuspid regurgitation grade (1)

  check the success of surgery /measure the size of the TR area

  immediately after the procedure

• change of tricuspid regurgitation grade (2)

  examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram

  immediately after the procedure

Secondary Outcomes (3)

• change of tricuspid regurgitation valve hemodynamics

  within 24 h of insertion

• evaluate the efficacy based on the function of early diagnosis (1)

  within 24 h of insertion

• evaluate the efficacy based on the function of early diagnosis (2)

  within 24 h of insertion

Study Arms (1)

Pivot Balloon

EXPERIMENTAL

mornitoring with transcatheter Tricuspid Regurgitation reduction system

Device: Pivot Balloon Catheter

Interventions

Pivot Balloon Catheter DEVICE

mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Pivot Balloon

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 20 years or above
• Target of Thoracic Surgery for TR and patients above the severe level on the criteria presented in the Classification of TR Grade based on echocardiogram, among those with TR, for whom a surgical treatment has been decided
• 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

You may not qualify if:

• Uncontrolled hyperthyroidism
• A recent formation of soft blood clot or embolic material
• Uncorrected coagulopathy
• Prohibition of anticoagulant agents
• Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker
• Presence of malignant tumor or benign tumor such as myxoma in the heart
• Presence of a symptom of active infection
• Chronic pulmonary disease
• Congenital tricuspid valve insufficiency
• Pregnant or lactating mother, or a female patient planning pregnancy during the period of clinical trial, or a female not using an approved contraceptive with the possibility of pregnancy
• Participation in another clinical trial 30 days prior to the screening
• In addition, anyone showing a clinical finding deemed to be unsuitable for the clinical trial by the Principal Investigator or the Investigator

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (10)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Hallym University Medical Center

Anyang, Dongan-gu, 14068, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50602, South Korea

Location

Chungnam National University Hospital (CNU Hospital)

Daejeon, Jung-gu, 35015, South Korea

Location

Yeungnam University Hospital

Daegu, Nam-gu, 42415, South Korea

Location

Ulsan Hospital

Ulsan, Nam-gu, 44686, South Korea

Location

Chungnam National University Sejong Hospital

Sejong, Sejong-si, 30099, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Bucheon Sejong Hospital

Bucheon-si, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

• Downie IP, Evans BT. Re: Holmes S, Hutchison I. Reconstruction of the orbital floor after its removal for malignancy. Br J Oral Maxillofac Surg 2001; 39: 158-159. Br J Oral Maxillofac Surg. 2001 Dec;39(6):485. doi: 10.1054/bjom.2001.0679. No abstract available.

  PMID: 11735152 BACKGROUND

• Kim EK, Chon MK, Kim HS, Park YH, Lee SH, Choo KS, Je HG, Kim DH, Kim TO, Koh YS, Park JH, Lee JH, Choi YJ, Shin ES, Yoon HJ, Lee SW, Hahn JY. Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences. Korean Circ J. 2025 Jan;55(1):20-31. doi: 10.4070/kcj.2024.0147. Epub 2024 Oct 14.

  PMID: 39601393 DERIVED

Study Officials

• Seung-Whan Lee, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: July 19, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

KR (10)