Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

NCT07172477 | Recruiting DMC

• 1 other identifier: TCP-EFS-12-AU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is

• To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention
• To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid Regurgitation; SPACER; Pivot Extend

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of the implantation of the "Pivot Extend" device

  Occurrence rate of major adverse cardiac events (MACE) (e.g. stroke, myocardial infarction, pulmonary embolism)

  30 days post device implantation

Secondary Outcomes (12)

• To evaluate the Pivot Extend device success

  During implantation procedure

• To evaluate the procedural success (1)

  30 days, 180 days and 365 days post device implantation

• To evaluate the procedural success (2)

  30 days, 180 days and 365 days post device implantation

• To evaluate the procedural success (3)

  180 and 365 days after device implantation

• To evaluate the procedural success (4)

  30 days, 180 days and 365 days post device implantation

Study Arms (1)

Pivot Extend device

EXPERIMENTAL

Patients aged 18 years or older with severe and symptomatic tricuspid regurgitation

Device: Pivot Extend

Interventions

Pivot Extend DEVICE

The investigational "Pivot Extend" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Extend 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.

Pivot Extend device

Eligibility Criteria

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

You may qualify if:

• Has voluntarily decided to participate in this clinical trial and has provided written informed consent
• Adults aged 18 years or older at the time of informed consent
• Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening
• Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit
• Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon
• Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study

You may not qualify if:

• Has 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
• Uncorrected blood clotting disorders based on hematology tests performed at the screening visit
• Unable to use anticoagulant agents (NOAC ex.Xarelto)
• A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial
• Severe anemia (hemoglobin less than or equal to 80g/L)
• Has an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker
• Has anatomy that, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit
• Requires surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
• Platelet count of 50 x 10\^9 per litre of blood or less based on hematology tests performed at the screening visit
• Pulmonary arterial hypertension, defined as pulmonary artery systolic pressure greater than 70mmHg on cardiac catheterization performed at the screening visit, or a pulmonary vascular resistance greater than 3 Wood Units on right heart catheterization
• Left ventricular ejection fraction (LVEF) of less than 20% on echocardiogram performed at the screening visit
• Active gastrointestinal bleeding or a digestive procedure within 90 days prior to screening for this study, and/or those with the potential for gastrointestinal bleeding in the opinion of the investigator
• History of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to screening for this clinical trial
• History of myocardial infarction (MI) within 30 days prior to screening for this study
• Active endocarditis requiring antibiotic treatment

Sponsors & Collaborators

• Tau Medical Australia Pty Ltd: lead
• Tau-MEDICAL Co., Ltd.: collaborator

Study Sites (1)

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• June-Hong Kim, PhD

  Tau-MEDICAL Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Alex (Jongyoon) Park

CONTACT

+82-(51)515-8783; jypark@tau-medical.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

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 15, 2025
• Study Start: November 11, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)