Clinical Evaluation of the TRVD™ System in ADHF

Study Overview
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Brief Summary
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A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction. The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention. Study participation, for each enrolled subject, will last approximately 3 months post index procedure. Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.

Official Title
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Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)

Conditions
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Acute Heart Failure, Congestive Heart Failure, Heart Failure, Congestive

Intervention / Treatment
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* Device: TRVD Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years of age or older Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic. Patient presents at least two of the following clinical signs of manifest volume overload: 3.1 Jugular venous distension 3.2 Dyspnea, rales, or evidence of pulmonary congestion or oedema on admission chest radiography 3.3 Abdominal discomfort compatible with internal organ congestion and/or hepatomegaly 3.4 Peripheral oedema Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm. BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL . Evidence of cardiac etiology as per cardiac ultrasonography. LVEF =/<40%. CVP (Invasively measured) >/=14 mmHg Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test). Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments. Exclusion Criteria: INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin. Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support. Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation <90% with supplemental oxygen), need for non-invasive positive pressure ventilation or intubation. Severe renal dysfunction (eGFR before decompensation <45 ml/min/1.73 m2 BSA or <25 on admission). Known renal artery stenosis. Known intrinsic kidney disease (e.g., established diagnosis of diabetic nephropathy with macroproteinuria, chronic glomerulonephritis). Severe anaemia (haemoglobin <9 mg/dL). Thrombocytopenia with a platelets count <100,000. Acute coronary syndrome within 4 weeks prior to admission. Active myocarditis or hypertrophic obstructive cardiomyopathy. Complex congenital heart disease. Severe valvular stenosis. Severe morbid obesity (BMI >35). Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.) Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment. Large ascites per ultrasound/CT. Cognitive impairment. Planned PCI, or more than minor surgery in the next 3 months. Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year. Patient has a known allergy to Nickel. Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRVD Therapy<br> | Device: TRVD Therapy<br>* A catheter-mounted expandable flow pump is to be deployed in a transfemoral venous catheterization procedure. Once in place, renal venous pressure is reduced to a pre-selected physiologic target pressure and kept there for up to 24 hours. After termination of TRVD therapy, the device is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Safety (device- and procedure-related SAEs) | Incidence of device- and procedure-related SAEs | 30 days post index procedure | 
| Feasibility (technical success) | Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge. | Hospital discharge (at least 96 hours following index procedure) | 
| Feasibility (procedural success) | Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge. | Hospital discharge (at least 96 hours following index procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial performance (effectiveness of renal venous pressure reduction) | Invasively assessed renal venous pressure reduction from baseline (in mmHg) | Up to 24 hours |