Trisol System EFS Study

• ClinicalTrials.gov Identifier: NCT04905017
• Recruitment Status: Recruiting
• First Posted: May 27, 2021
• Last Update Posted: February 7, 2024
• Sponsor: Trisol Medical
• Information provided by (Responsible Party): Trisol Medical

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Tricuspid Regurgitation	Device: Transcatheter Tricuspid Valve Replacement	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Feasibility Study of the Trisol System
• Actual Study Start Date: March 2, 2022
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: July 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment with the Trisol System	Device: Transcatheter Tricuspid Valve Replacement; Replacement of the tricusupid valve using Trisol System in a transcatheter approach

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Ron Davidson, B. Sc., MBA; +972 528998866; rond@trisol-medical.com

Locations

United States, Georgia

Piedmont Heart Institute; Recruiting

Atlanta, Georgia, United States, 30309

Contact: Caryn Bernstein, MN FNP-BC CCRC 404.605.5688 caryn.bernstein@piedmont.org

Principal Investigator: Vinod Thourani, MD

Principal Investigator: Pradeep K Yadav, MD

United States, New York

Columbia University Medical Center/NYPH; Not yet recruiting

New York, New York, United States, 10032

Contact: Kate Dalton, MS, RD 347-514-3366 keb2114@cumc.columbia.edu

United States, Pennsylvania

Main Line Health / Lankenau Institute for Medical Research; Not yet recruiting

Wynnewood, Pennsylvania, United States, 19096

Contact: Ann Marie Chikowski, MBA, RN, CCRC 484.476.8579 Chikowskia@MLHS.ORG

Principal Investigator: William Gray, MD FACC FSCAI

United States, Virginia

University of Virginia Cardiology; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Linda Bailes Bryceland, RN 434-982-1058 SL9PC@virginia.edu

Sponsors and Collaborators

Trisol Medical

Investigators

• Principal Investigator: Isaac George, MD; Columbia University

More Information

• Responsible Party: Trisol Medical
• ClinicalTrials.gov Identifier: NCT04905017
• Other Study ID Numbers: DMS-10809
• First Posted: May 27, 2021
• Last Update Posted: February 7, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases