Clinical trial NCT05648838: Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Tricuspid Regurgitation
Keywords: FTR
RV failure
TauPnu
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* 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

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
* 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

Primary outcomes:
measure: change of tricuspid regurgitation grade (1)
timeFrame: immediately after the procedure
measure: change of tricuspid regurgitation grade (2)
timeFrame: immediately after the procedure
Secondary outcomes:
measure: change of tricuspid regurgitation valve hemodynamics
timeFrame: within 24 h of insertion
measure: evaluate the efficacy based on the function of early diagnosis (1)
timeFrame: within 24 h of insertion
measure: evaluate the efficacy based on the function of early diagnosis (2)
timeFrame: within 24 h of insertion
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Dongan-gu
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNU Hospital)
state: Jung-gu
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
state: Nam-gu
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
state: Sejong-si
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon-si
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seung-Whan Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.