Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
ConditionTricuspid Regurgitation (TR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTau-MEDICAL Co., Ltd.
About this trial
This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device.
1. Determine the safety of long-term implantation of the investigational medical device "Pivot Extend" by monitoring for MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation. 2. Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.
Eligibility criteria
Qualifiers
Adults 18 years of age or older at the time of screening
Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
Disqualifiers
Those with blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
Trial design
Treatments tested in this trial
- Pivot Extend Tricuspid Regurgitation Spacer Device
Treatment groups
7 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov