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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pivot Extend Tricuspid Regurgitation Spacer Device
DeviceThe Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator.
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Treatment to Improve TR Symptoms with Investigational Medical Device ImplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Cardiac Events(MACEs)
Occurrence Ratio of Major Adverse Cardiac Events (MACEs)
Time frame
1 month post-procedureSecondary outcomes
1
Device Success
The rate of the device successfully placed at target location
Time frame
during procedure2
Procedural Success(1)
Changes in TR Grade: The number of the participants who had at least 1 TR grade drop, confirmed through echocardiography
Time frame
1-month, 6-month, 12-month post-procedure3
Procedural Success(2)
The occurrence rate of MACEs associated with the trial device or procedure
Time frame
1-month, 6-month, 12-month post-procedure4
Clinical Outcomes(1)
Changes in anatomical structure: Changes in right ventricular volume from baseline confirmed through cardiac CT
Time frame
6-month, 12-month post-procedureSponsors and contacts
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Source ClinicalTrials.gov