Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Heart Failure
- Sponsor
- Magenta Medical Ltd.
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Feasibility (procedural success)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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,
- •Acute coronary syndrome within 4 weeks prior to admission.
- •Active myocarditis or hypertrophic obstructive cardiomyopathy.
Outcomes
Primary Outcomes
Feasibility (procedural success)
Time Frame: Hospital discharge (at least 96 hours following index procedure)
Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge.
Feasibility (technical success)
Time Frame: Hospital discharge (at least 96 hours following index procedure)
Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge.
Preliminary Safety (device- and procedure-related SAEs)
Time Frame: 30 days post index procedure
Incidence of device- and procedure-related SAEs
Secondary Outcomes
- Initial performance (effectiveness of renal venous pressure reduction)(Up to 24 hours)