Clinical trial NCT04289870: Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
Official title: Prospective, Single Arm, Multi-center, First-in-human (FIH) Study to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft for the Treatment of Severe Tricuspid Regurgitation (TR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid Valve
Tricuspid Valve Insufficiency
Tricuspid Regurgitation
Lead sponsor: Innoventric LTD
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First In Human study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Safety Endpoint
timeFrame: Evaluated immediately after intervention, discharge and 30 days
measure: Technical performance
timeFrame: Evaluated immediately after intervention
measure: Efficacy Endpoint
timeFrame: Evaluated immediately after intervention
Secondary outcomes:
measure: Safety Endpoint
timeFrame: Assessment at 3-month, 6-month and 1-year
measure: Efficacy Endpoint
timeFrame: Assessment at 30 days, 3-month, 6-month and 1-year
Other outcomes:
measure: Other Endpoints
timeFrame: Assessment at 30 days, 3-month, 6-month and 1-year
Locations:
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Antwerp
country: Belgium
facility: ZNA
city: Bad Oeynhausen
country: Germany
facility: Heart & Diabetes Center NRW
city: Berlin
country: Germany
facility: Herzzentrum der Charité (DHZC)
city: Leipzig
country: Germany
facility: Leipzig Heart Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro, Hospital Universitario de Vigo
Study officials:
References: