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

Tau-Medical

Status

Completed

Conditions

Functional Tricuspid Regurgitation

Treatments

Device: Pivot Bridge

Study type

Interventional

Funder types

Industry

Identifiers

NCT05854095

Pivot Bridge-FIM

Details and patient eligibility

About

evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation

Full 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

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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