The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat… (NCT05854095) | Clinical Trial Compass
CompletedNot Applicable
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
South Korea15 participantsStarted 2023-03-13
Plain-language summary
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 â…¡ 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 …