Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
Study Details
Study Description
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.
Fifteen (15) patients in 5 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Innoventric Trillium™ Stent Graft Single Arm Single-arm, open label, multi-center study |
Device: Trillium™
Trillium™ Stent Graft for Functional Tricuspid Valve Replacement
|
Outcome Measures
Primary Outcome Measures
- Safety Endpoint [Evaluated at 30 days]
The primary safety endpoint is freedom-from major device- or procedure-related serious adverse events including: death, stroke, life-threatening bleeding (MVARC scale), major vascular complications, major cardiac structural complications, stage 2 or 3 AKI, MI or coronary ischemia requiring PCI or CABG, severe hypotension, HF or respiratory failure requiring intravenous pressors or invasive mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices including intra-aortic balloon pumps (IABP) or left ventricular or biventricular assist devices, or prolonged intubation (≥48h), or device-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- Technical success [Assessment at the time of the patient's exit from the cardiac catheterization lab]
Measured at the time of the patient's exit from the cardiac catheterization lab, reflects the ability of the user to deploy the device as intended and retrieve the delivery system without procedural mortality or need for emergency surgery or re-intervention. For technical success to be achieved, all the following must be present at exit from the catheterization laboratory: Freedom from procedural mortality Successful access, delivery and retrieval of delivery system Successful deployment and correct positioning of the first intended device Freedom from emergency surgery or re-intervention related to the device or access procedure
- Device success [up to 72 hours]
Characterizes the acute "technical" performance of the device and delivery system as well as the effectiveness of the device. For device success to be achieved, all the following must be present (primary assessment at discharge): Absence of procedural mortality or stroke Proper placement and positioning of the device Freedom from unplanned surgical or re-interventions related to the device or access procedure Continued safety of the device including no evidence of structural or functional failure, no evidence of specific device-related technical issues and complications Acceptable performance of the device defined as a reduction in hepatic vein systolic backflow to moderate (systolic blunting) or better as measured by transthoracic echocardiography (TTE)
- Procedural success [Assessment at 30 days]
A composite safety and efficacy endpoint that characterizes the early outcome of the tricuspid interventional procedure. For procedural success to be achieved, all the following must be present (primary assessment at 30 days): Device success Absence of major device- or procedure-related serious adverse events including: death, stroke, life-threatening bleeding (MVARC scale), major vascular complications, major cardiac structural complications, stage 2 or 3 AKI, MI or coronary ischemia requiring PCI or CABG, severe hypotension, HF, or respiratory failure requiring intravenous pressors or invasive mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices including intra-aortic balloon pumps (IABP) or left ventricular or biventricular assist devices, or prolonged intubation (≥48h), or device-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- Patient success [Assessment at 6-months]
Reflects the effectiveness of the TV intervention in improving overall clinical outcomes. For patient success to be achieved, all the following must be present (primary assessment at 6 months): Procedural Success Patient returned to the pre-procedural level of care (or less intensive level of care) No hospitalizations or re-interventions for HF or TR No worsening of HF functional class (NYHA), At least one of the following: Improved HF functional class from baseline (NYHA≥1 class lower) Improved exercise tolerance from baseline (6MWT change ≥50m further) Improved QOL from baseline (KCCQ change ≥ 10 higher)
Secondary Outcome Measures
- Device success [Assessment at 30 days, 3-month, 6-month and 1-year]
Characterizes the acute "technical" performance of the device and delivery system as well as the effectiveness of the device. For device success to be achieved, all the following must be present: Absence of procedural mortality or stroke Proper placement and positioning of the device Freedom from unplanned surgical or re-interventions related to the device or access procedure Continued safety of the device including no evidence of structural or functional failure, no evidence of specific device-related technical issues and complications. Acceptable performance of the device defined as a reduction in hepatic vein systolic backflow to moderate (systolic blunting) or better as measured by transthoracic echocardiography (TTE)
- Procedural success [Assessment at 3-month, 6-month and 1-year]
A composite safety and efficacy endpoint that characterizes the early outcome of the tricuspid interventional procedure. For procedural success to be achieved, all the following must be present: Device success Absence of major device- or procedure-related serious adverse events including: death, stroke, life-threatening bleeding (MVARC scale), major vascular complications, major cardiac structural complications, stage 2 or 3 AKI, MI or coronary ischemia requiring PCI or CABG, severe hypotension, HF, or respiratory failure requiring intravenous pressors or invasive mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices including intra-aortic balloon pumps (IABP) or left ventricular or biventricular assist devices, or prolonged intubation (≥48h), or device-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- Patient success [Assessment at 1 year]
Reflects the effectiveness of the TV intervention in improving overall clinical outcomes. For patient success to be achieved, all the following must be present : Procedural Success Patient returned to the pre-procedural level of care (or less intensive level of care) No hospitalizations or re-interventions for HF or TR No worsening of HF functional class (NYHA), At least one of the following: Improved HF functional class from baseline (NYHA≥1 class lower) Improved exercise tolerance from baseline (6MWT change ≥50m further) Improved QOL from baseline (KCCQ change ≥ 10 higher)
Eligibility Criteria
Criteria
Inclusion Criteria:
Enrolled patients must meet ALL the following criteria:
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Age >40 (no upper limit)
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Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm2
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Symptomatic despite medical therapy; patient must be on diuretic therapy.
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Peak central venous pressure of > 15mmHg
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The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
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Patient is willing and able to comply with all specified study evaluations.
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Patient has NYHA functional classification of III or IV
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Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic.
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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:
- Echocardiographic parameters (Any of the following):
- LVEF < 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE < 13.0 mm) III. IVC or SVC anatomy that precludes proper device deployment and function
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Systolic Pulmonary Artery Pressure > 70mmHg
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Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
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Active endocarditis within 90 days of the scheduled implant
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Significant pericardial effusion
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Intra-cardiac masses, thrombi, or vegetation
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Thrombosis of the venous system
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Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves
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Untreated clinically significant coronary artery disease requiring immediate revascularization
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MI or known unstable angina within 30 days prior to the index procedure
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Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure
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Any prior cardiac surgery, within 3 months of the index procedure
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Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure
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Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)
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Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg)
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Cerebrovascular Accident (CVA) within the past 90 days
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Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 or patient is on chronic dialysis
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Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure
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Chronic liver disease with a MELD score of 12 or greater
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Chronic anemia (Hb < 9 g/L) not corrected by transfusion
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Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
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Bleeding disorders or hypercoagulable state
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Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
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Contraindication to anticoagulants or antiplatelet agents
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Currently or history of IV drug use
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Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
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Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
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Impaired judgment
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Undergoing emergent or urgent treatment for tricuspid insufficiency
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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
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Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months
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Cardiac cachexia
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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
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Patient is under guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart & Diabetes Center NRW | Bad Oeynhausen | Germany | 32545 | |
| 2 | Leipzig Heart Center | Leipzig | Germany | ||
| 3 | Rabin Medical Center | Petah tikva | Israel | 4941492 | |
| 4 | Sheba MC | Ramat Gan | Israel | ||
| 5 | Kaplan MC | Rehovot | Israel |
Sponsors and Collaborators
- Innoventric LTD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLD-001