Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study

Innoventric

Status: Active, not recruiting

Conditions: Tricuspid Regurgitation

Treatments: Device: Trillium™

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289870

CLD-001

Details and patient eligibility

About

A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System.

Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Enrolled patients must meet ALL the following criteria:

1. Age >40 (no upper limit)
2. Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm^2
3. Symptomatic despite medical therapy; patient must be on diuretic therapy.
4. Peak central venous pressure of ≥ 15mmHg
5. The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
6. Patient is willing and able to comply with all specified study evaluations.
7. Patient has NYHA functional classification of III or IV
8. Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
9. Patient understands the nature of the study and study requirements and is willing to provide written Informed Consent prior to any study-specific procedures.

Exclusion criteria

Patients will be excluded from participation if ANY of the following criteria apply:

1. Echocardiographic parameters (Any of the following):

   I. LVEF < 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE < 13.0mm) III. IVC or SVC anatomy that precludes proper device deployment and function

2. Systolic Pulmonary Artery Pressure > 70mmHg

3. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation

4. Active endocarditis within 90 days of the scheduled implant

5. Significant pericardial effusion

6. Intra-cardiac masses, thrombi, or vegetation

7. Thrombosis of the venous system

8. Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves

9. Untreated clinically significant coronary artery disease requiring immediate revascularization

10. MI or known unstable angina within 30 days prior to the index procedure

11. Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure

12. Any prior cardiac surgery, within 3 months of the index procedure

13. Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure

14. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)

15. Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg)

16. Cerebrovascular Accident (CVA) within the past 90 days

17. Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m^2 or patient is on chronic dialysis

18. Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure

19. Chronic liver disease with a MELD score of 20 or greater

20. Chronic anemia (Hb < 9 g/L) not corrected by transfusion

21. Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)

22. Bleeding disorders or hypercoagulable state

23. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant

24. Contraindication to anticoagulants or antiplatelet agents

25. Currently or history of IV drug use

26. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.

27. Inability to access the femoral vein with a 24 FR guide (e.g., DVT, occluded femoral veins).

28. Known allergy to stainless steel, nickel, titanium, PET or contrast agents that cannot be adequately pre-medicated.

29. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

30. Impaired judgment

31. Undergoing emergent or urgent treatment for tricuspid insufficiency

32. 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

33. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months

34. Cardiac cachexia

35. In the judgment of the Investigator, co-morbid condition(s) that 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

36. Patient is under guardianship

37. Presence of any prosthetic device in the SVC or IVC (excluding pace-maker, ICD and CRT leads)

38. Elevated inflammatory markers within 2 weeks of the scheduled procedure (e.g. CRP>1.5mg/dL).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Innoventric Trillium™ Stent Graft Single Arm

Experimental group

Description:

Single-arm, open label, multi-center study

Treatment:

Device: Trillium™