Clinical trial NCT04905017: Trisol System EFS Study
Official title: Early Feasibility Study of the Trisol System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Trisol Medical
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Eligibility 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.

Primary outcomes:
measure: Rate of device-related serious adverse events
timeFrame: Up to 30 days
measure: Rate of technical success
timeFrame: During procedure
measure: Rate of procedural success
timeFrame: Up to 30 days
measure: Change in TR from baseline
timeFrame: During procedure
Secondary outcomes:
measure: Clinical performance endpoints - Change in TR from baseline
timeFrame: At 30 days, 6 months, 12 months
measure: Clinical performance endpoints - Change in NYHA class
timeFrame: At 30 days, 6 months, 12 months, and then annually
measure: Clinical performance endpoints --minute walk test
timeFrame: At 30 days, 6 months and 12 months
measure: Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
timeFrame: At 30 days, 6 months and 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Wynnewood
country: United States
facility: Main Line Health / Lankenau Institute for Medical Research
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Cardiology
state: Virginia
Study officials:
affiliation: Columbia University
name: Isaac George, MD
role: PRINCIPAL_INVESTIGATOR
References: