Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

NCT06877520 | Recruiting

• 1 other identifier: TCP-EFS-07-GE
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 2.Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.

Conditions

Tricuspid Regurgitation (TR)

Keywords

Pivot Extend; TauMedical

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events(MACEs)

  Occurrence Ratio of Major Adverse Cardiac Events (MACEs)

  1 month post-procedure

Secondary Outcomes (9)

• Device Success

  during procedure

• Procedural Success(1)

  1-month, 6-month, 12-month post-procedure

• Procedural Success(2)

  1-month, 6-month, 12-month post-procedure

• Clinical Outcomes(1)

  6-month, 12-month post-procedure

• Clinical Outcomes(2)

  1-month, 6-month, 12-month post-procedure

Study Arms (1)

Treatment to Improve TR Symptoms with Investigational Medical Device Implantation

EXPERIMENTAL

Participants assigned to this arm will receive an investigational medical device designed to improve symptoms of severe and clinically symptomatic tricuspid regurgitation (TR). Following device implantation, participants will be monitored in a specialized facility for at least 24 hours with real-time observation of vital signs. The device's safety and efficacy will be assessed over 12 months through scheduled visits, with clinical progress monitored throughout. Device removal may be performed if adverse events occur or if deemed necessary by the investigator.

Device: Pivot Extend Tricuspid Regurgitation Spacer Device

Interventions

Pivot Extend Tricuspid Regurgitation Spacer Device DEVICE

The 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 to Improve TR Symptoms with Investigational Medical Device Implantation

Eligibility Criteria

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

You may qualify if:

• 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
• Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
• Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent
• Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study

You may not qualify if:

• 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
• Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
• Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
• Those whose anatomy, 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
• Those who require 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
• Those with a platelet count of 80,000/uL or less based on hemanalysis performed at the screening visit
• Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart catheterization
• Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit
• Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential for gastrointestinal bleeding)
• Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial
• Those with a history of myocardial infarction (MI) within 30 days prior to participation in this study
• Those with active endocarditis requiring antibiotic treatment

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (3)

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, K'alak'i T'bilisi, 0102, Georgia

RECRUITING

Tbilisi Heart and Vascular Clinic

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

RECRUITING

Tbilisi Heart Center

Tbilisi, K'alak'i T'bilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Markus Reinthaler, MD, PhD

CONTACT

+49 (0) 157 37972007; reinthal@gmail.com

Seung-Whan Lee, MD, PhD

CONTACT

+82 1688-7575; seungwlee@amc.seoul.kr

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: Multi-center, open label, single arm, early feasibility study

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

GE (3)