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

Functional Tricuspid Regurgitation Clinical Trial

Official title:

The Study for Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of Functional Tricuspid Regurgitation : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648838
• Other study ID #: Pivot Balloon-FIM
• Status: Completed
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: March 2023
• Source: Tau Pnu Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The study for evaluation of safety and efficacy of Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilot study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult males and females aged 20 years or above
• Target of Thoracic Surgery for TR,[11] and patients above the severe level on the criteria presented in the Classification of TR Grade (Tabe 1) based on echocardiogram, among those with TR, for whom a surgical treatment has been decided *patients with left valve disease, left ventricular failure, and pulmonary arterial hypertension in addition to functional tricuspid regurgitation can be selected
• 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
• 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
• Severe pulmonary arterial hypertension with a right ventricular systolic pressure (RVSP) of 70 mmHg or higher
• 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

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Pivot Balloon Catheter
mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Dongan-gu
Korea, Republic of	Bucheon Sejong Hospital	Bucheon-si
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Dalseo-gu
Korea, Republic of	Yeungnam University Hospital	Daegu	Nam-gu
Korea, Republic of	Chungnam National University Hospital (CNU Hospital)	Daejeon	Jung-gu
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong	Bodeum7ro
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Ulsan Hospital	Ulsan	Nam-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of tricuspid regurgitation grade (1)	check the success of surgery /measure the size of the TR area	immediately after the procedure
Primary	change of tricuspid regurgitation grade (2)	examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram	immediately after the procedure
Secondary	change of tricuspid regurgitation valve hemodynamics	examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram	within 24 h of insertion
Secondary	evaluate the efficacy based on the function of early diagnosis (1)	examine tricuspid regurgitation intolerance	within 24 h of insertion
Secondary	evaluate the efficacy based on the function of early diagnosis (2)	evaluate the technical success rate of the implantation and the technical feasibility of 'Pivot Balloon'	within 24 h of insertion