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Study identifier: NCT06877520 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

Condition: Tricuspid Regurgitation (TR)  ·  Sponsor: Tau-MEDICAL Co., Ltd.

PhaseNA
Planned participants7
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Markus Reinthaler, MD, PhD  ·  +49 (0) 157 37972007  ·  reinthal@gmail.com

Seung-Whan Lee, MD, PhD  ·  +82 1688-7575  ·  seungwlee@amc.seoul.kr

Always discuss trial participation with your own doctor first.

Locations (3)

Israeli-Georgian Medical Research Clinic HealthycoreTbilisi, K'alak'i T'bilisi, GeorgiaRecruiting
Tbilisi Heart and Vascular ClinicTbilisi, K'alak'i T'bilisi, GeorgiaRecruiting
Tbilisi Heart CenterTbilisi, K'alak'i T'bilisi, GeorgiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06877520