Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation

NCT07385625 | Recruiting DMC

• 1 other identifier: TCP-IT2-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who have received medical therapy (diuretics/pharmacological treatment) for at least one month. To evaluate clinical outcomes related to improvement of tricuspid regurgitation symptoms following implantation of the "Pivot Bridge" device, including procedure success and clinical success. This study is designed as a self-controlled case series without a separate control group. The participant's non-exposure period to the investigational medical device, consisting of prior medical therapy (Medical Treatment, MT), is defined as the control period. The study compares (1) a period of fixed-dose medical therapy maintained for up to one week prior to application of the investigational medical device, and (2) a period during which the investigational medical device is temporarily implanted (within 1 week) in conjunction with medical therapy (Pivot Bridge, PB). To quantitatively evaluate the efficacy of the investigational medical device in inducing improvement of tricuspid regurgitation, the following are assessed:

1. 1.improvement in regurgitation severity from baseline to Day 4-7 during fixed-dose medical therapy (ΔMT), and
2. 2.improvement from pre-application to the time of device removal following additional application of the Pivot Bridge (ΔPB).

Conditions

Tricuspid Regurgitation Functional

Keywords

Tricuspid Regurgitation; SPACER; Pivot Bridge

Outcome Measures

Primary Outcomes (1)

• Procedure Success Based on Improvement in Tricuspid Regurgitation Severity

  Proportion of subjects achieving at least a 1-grade improvement in tricuspid regurgitation (TR grade) according to Tricuspid Valve Academic Research Consortium definitions

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

Secondary Outcomes (13)

• Clinical Success Based on Clinical Improvement

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

• Clinical Success Based on Clinical Improvement(1)

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

• Clinical Success Based on Clinical Improvement(2)

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

• Clinical Success Based on Clinical Improvement(3)

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

• Clinical Success Based on Clinical Improvement(4)

  Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)

Study Arms (1)

Patients ≥18 Years With Massive or Greater Functional Tricuspid Regurgitation on Medical Therapy

EXPERIMENTAL

Patients aged 18 years or older with massive or greater functional tricuspid regurgitation who have received medical therapy (diuretics and/or pharmacological treatment) for at least 1 month

Device: Pivot Bridge

Interventions

Pivot Bridge DEVICE

The investigational "Pivot Bridge" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Bridge device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.

Patients ≥18 Years With Massive or Greater Functional Tricuspid Regurgitation on Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all of the following criteria will be enrolled
• Adults aged 18 years or older at the time of screening
• Subjects who have received appropriate medical treatment (diuretics/medical therapy) for tricuspid regurgitation for at least 1 month prior to participation in this clinical trial
• Subjects who, at the screening visit, are assessed by transthoracic echocardiography (TTE) to have functional tricuspid regurgitation severity of Massive (4+) or greater, as defined by Tricuspid Valve Academic Research Consortium classification, and who have clinical symptoms corresponding to New York Heart Association (NYHA) functional class II or higher
• Subjects who, at the screening visit, are found on TTE or cardiac computed tomography (CT) to have a right ventricle (RV) larger than the left ventricle (LV)
• Subjects who, at the screening visit, are found on cardiac CT to have an annular diameter of 40 mm or greater
• Subjects for whom the Heart Team, consisting of at least one cardiologist (specialist in cardiology) and at least one cardiac surgeon, has determined that surgical treatment for isolated Tricuspid Regurgitation is required
• Subjects who voluntarily decide to participate in this clinical trial and provide written informed consent on the subject consent form
• Subjects who are able to understand and comply with the investigator's instructions and participate throughout the entire clinical trial period

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded
• Subjects in whom thrombus or embolic material is identified on echocardiography or cardiac computed tomography (CT) performed at the screening visit
• Subjects who have uncorrected coagulation disorders as shown by clinical laboratory tests performed at the screening visit
• Subjects who cannot use anticoagulant agents
• Subjects who, prior to participation in this clinical trial, have experienced major bleeding due to the use of anticoagulants (minor bleeding such as controllable epistaxis does not apply) requiring treatment, or who have had severe anemia necessitating hospitalization
• Subjects who, prior to participation in this clinical trial, have had devices such as an implantable cardioverter defibrillator (ICD) or a pacemaker implanted
• Subjects who, based on echocardiography and cardiac CT performed at the screening visit, are judged by the investigator to have anatomical structures unsuitable for implantation of the investigational medical device
• Subjects who, based on clinical laboratory tests performed at the screening visit, have a platelet count of ≤80,000/µL
• Subjects who, based on echocardiography performed at the screening visit, have pulmonary hypertension with TR Vmax ≥3.5 m/s
• Subjects who, based on echocardiography performed at the screening visit, have left ventricular ejection fraction (LVEF) \<50%
• Subjects who, within 3 months prior to participation in this clinical trial, have had active gastrointestinal bleeding or have undergone gastrointestinal procedures (subjects with a risk of gastrointestinal bleeding)
• Subjects who, within 30 days prior to participation in this clinical trial, have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Subjects who, within 30 days prior to participation in this clinical trial, have a history of myocardial infarction (MI)
• Subjects with active infective endocarditis requiring antibiotic therapy
• Subjects with severe terminal illnesses (e.g., malignant tumors, end-stage pulmonary disease, end-stage liver disease, end-stage renal failure)

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (4)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50602, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Geu-Ru Hong, MD, PhD

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June-Hong Kim, MD, PhD

CONTACT

+82-(51)515-8783; junehongk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study uses a self-controlled case series design in which each participant serves as their own control, with the period of prior medical therapy (Medical Treatment, MT) defined as the control period.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)