Trisol System EFS Study

February 6, 2024 updated by: Trisol Medical

Early Feasibility Study of the Trisol System

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).

Study Overview

Status

Recruiting

Detailed Description

A prospective, single-arm, open-label, multi-center early feasibility clinical study.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • Principal Investigator:
          • Pradeep K Yadav, MD
        • Principal Investigator:
          • Vinod Thourani, MD
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center/NYPH
        • Contact:
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Not yet recruiting
        • Main Line Health / Lankenau Institute for Medical Research
        • Contact:
        • Principal Investigator:
          • William Gray, MD FACC FSCAI
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cardiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >18 years.
  2. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
  3. 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).
  4. New York Heart Association (NYHA) Functional Class II to IVa.
  5. 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.
  6. 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.
  7. Male or non-pregnant female.
  8. Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
  9. Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
  10. Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee

Exclusion Criteria:

  1. Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
  2. Stroke or transient ischemic event within the previous 90 days.
  3. Acute myocardial infarction within the previous 90 days.
  4. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
  5. Untreated clinically significant coronary artery disease requiring revascularization.
  6. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
  7. New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
  8. Systolic pulmonary arterial pressure (sPAP) > 80 mmHg as measured by pulmonary pressure catheter.
  9. Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat <400 and Pulmonary Artery Pulsatile index (PAPi) <2.
  10. Ongoing sepsis, including active endocarditis.
  11. Active infection requiring current antibiotic therapy.
  12. Known bleeding diathesis or hypercoagulable state.
  13. Blood dyscrasias as defined: leukopenia (WBC <3000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3).
  14. Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
  15. LVEF <25% as measured by resting echocardiogram within 30 days prior to index procedure.
  16. Patients in whom transesophageal echocardiography is contraindicated.
  17. Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.
  18. Severe tricuspid valve stenosis.
  19. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.
  20. Need for emergent or urgent non cardiac surgery for any reason.
  21. Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.
  22. History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).
  23. Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.
  24. Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy.
  25. Venous anatomy unsuitable for implant delivery.
  26. Pacemaker or ICD lead present that would prevent appropriate valve placement.
  27. Active COVID-19 infection.
  28. Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
  29. Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with the Trisol System
Replacement of the tricusupid valve using Trisol System in a transcatheter approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of device-related serious adverse events
Time Frame: Up to 30 days
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
Time Frame: During procedure
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
During procedure
Rate of procedural success
Time Frame: Up to 30 days
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
Time Frame: During procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance endpoints - Change in TR from baseline
Time Frame: At 30 days, 6 months, 12 months
Change in TR from baseline: reduction in TR grade as compared to baseline TR grade, based on TTE imaging
At 30 days, 6 months, 12 months
Clinical performance endpoints - Change in NYHA class
Time Frame: At 30 days, 6 months, 12 months, and then annually
New York Heart Association (NYHA) functional class: change in NYHA from baseline
At 30 days, 6 months, 12 months, and then annually
Clinical performance endpoints --minute walk test
Time Frame: At 30 days, 6 months and 12 months
Six-minute walk test: change in distance (m) from baseline
At 30 days, 6 months and 12 months
Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Time Frame: At 30 days, 6 months and 12 months
Clinical performance endpoints -Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
At 30 days, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Isaac George, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 23, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DMS-10809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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