Status:
ACTIVE_NOT_RECRUITING
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
Lead Sponsor:
Innoventric LTD
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
40+ years
Phase:
NA
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 si...
Eligibility Criteria
Inclusion
- Enrolled patients must meet ALL the following criteria:
- Age \>40 (no upper limit)
- 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
- Symptomatic despite medical therapy; patient must be on diuretic therapy.
- Peak central venous pressure of ≥ 15mmHg
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
- Patient is willing and able to comply with all specified study evaluations.
- Patient has NYHA functional classification of III or IV
- 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
- 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
- Patients will be excluded from participation if ANY of the following criteria apply:
- 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
- Systolic Pulmonary Artery Pressure \> 70mmHg
- Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- Active endocarditis within 90 days of the scheduled implant
- Significant pericardial effusion
- Intra-cardiac masses, thrombi, or vegetation
- Thrombosis of the venous system
- Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves
- Untreated clinically significant coronary artery disease requiring immediate revascularization
- MI or known unstable angina within 30 days prior to the index procedure
- Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure
- Any prior cardiac surgery, within 3 months of the index procedure
- Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure
- Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)
- Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg)
- Cerebrovascular Accident (CVA) within the past 90 days
- Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 m\^2 or patient is on chronic dialysis
- Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure
- Chronic liver disease with a MELD score of 20 or greater
- Chronic anemia (Hb \< 9 g/L) not corrected by transfusion
- Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3)
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
- Contraindication to anticoagulants or antiplatelet agents
- Currently or history of IV drug use
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
- Inability to access the femoral vein with a 24 FR guide (e.g., DVT, occluded femoral veins).
- Known allergy to stainless steel, nickel, titanium, PET or contrast agents that cannot be adequately pre-medicated.
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- Impaired judgment
- Undergoing emergent or urgent treatment for tricuspid insufficiency
- 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
- Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months
- Cardiac cachexia
- 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
- Patient is under guardianship
- Presence of any prosthetic device in the SVC or IVC (excluding pace-maker, ICD and CRT leads)
- Elevated inflammatory markers within 2 weeks of the scheduled procedure (e.g. CRP\>1.5mg/dL).
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04289870
Start Date
June 24 2020
End Date
June 1 2026
Last Update
March 7 2025
Active Locations (9)
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1
OLVZ Aalst
Aalst, Belgium
2
ZNA
Antwerp, Belgium
3
Heart & Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
4
Herzzentrum der Charité (DHZC)
Berlin, Germany