NCT04905017

Brief Summary

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
63mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Mar 2022Jul 2031

First Submitted

Initial submission to the registry

May 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Expected
Last Updated

November 21, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

May 20, 2021

Last Update Submit

November 18, 2025

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (4)

  • Rate of device-related serious adverse events

    Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure

    Up to 30 days

  • Rate of technical success

    Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.

    During procedure

  • Rate of procedural success

    Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction

    Up to 30 days

  • Change in TR from baseline

    Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.

    During procedure

Secondary Outcomes (4)

  • Clinical performance endpoints - Change in TR from baseline

    At 30 days, 6 months, 12 months

  • Clinical performance endpoints - Change in NYHA class

    At 30 days, 6 months, 12 months, and then annually

  • Clinical performance endpoints --minute walk test

    At 30 days, 6 months and 12 months

  • Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire

    At 30 days, 6 months and 12 months

Study Arms (1)

Treatment with the Trisol System

EXPERIMENTAL
Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricusupid valve using Trisol System in a transcatheter approach

Treatment with the Trisol System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years.
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
  • Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
  • New York Heart Association (NYHA) Functional Class II to IVa.
  • Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
  • Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
  • Male or non-pregnant female.
  • Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
  • Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
  • Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee

You may not qualify if:

  • Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
  • Stroke or transient ischemic event within the previous 90 days.
  • Acute myocardial infarction within the previous 90 days.
  • Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
  • New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
  • Systolic pulmonary arterial pressure (sPAP) \> 80 mmHg as measured by pulmonary pressure catheter.
  • Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat \<400 and Pulmonary Artery Pulsatile index (PAPi) \<2.
  • Ongoing sepsis, including active endocarditis.
  • Active infection requiring current antibiotic therapy.
  • Known bleeding diathesis or hypercoagulable state.
  • Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3).
  • Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
  • LVEF \<25% as measured by resting echocardiogram within 30 days prior to index procedure.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Main Line Health / Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

University of Virginia Cardiology

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Isaac George, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Davidson, B. Sc., MBA

CONTACT

+972 528998866rond@trisol-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

May 20, 2021

First Posted

May 27, 2021

Study Start

March 2, 2022

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2031

Last Updated

November 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(7)