Clinical evaluation of the Transcatheter Renal Venous Decongestion (TRVD) System for renal venous decongestion in patients with Acute Decompensated Heart Failure (ADHF)

Completed

• Conditions: Acute Decompensated Heart Failure; Heart failure; 10019280; 10038365

• Registration Number: NL-OMON46072
• Lead Sponsor: Magenta Medical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Patient is 18 years of age or older
2. Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic.
3. 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
4. Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm.
5. BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL .
6. Evidence of cardiac etiology as per cardiac ultrasonography.
7. LVEF 8. CVP (Invasively measured) >/<= 14 mmHg
9. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test).
10. Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
11. Patient is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.

Exclusion Criteria

Clinical and general criteria: ;1. INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin.
2. Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support.
3. Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation <90% with supplemental oxygen), need for non-invasive positive pressure ventilation or intubation.
4. Severe renal dysfunction (eGFR before decompensation <45 ml/min/1.73 m2 BSA or <25 on admission).
5. Known renal artery stenosis.
6. Known intrinsic kidney disease (e.g., established diagnosis of diabetic nephropathy with macroproteinuria, chronic glomerulonephritis).
7. Severe anaemia (haemoglobin 8. Thrombocytopenia with a platelets count <100,000.
9. Acute coronary syndrome within 4 weeks prior to admission.
10. Active myocarditis or hypertrophic obstructive cardiomyopathy.
11. Complex congenital heart disease.
12. Severe valvular stenosis.
13. Severe morbid obesity (BMI >35).
14. Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.)
15. Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment.
16. Large ascites per ultrasound/CT.
17. Cognitive impairment.
18. Planned PCI, or more than minor surgery in the next 3 months.
19. Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year.
20. Patient has a known allergy to Nickel.
21. Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
22. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. ;CT Imaging: ;Patient has renal venous anatomy that is unsuitable for device placement for treatment,
including:
23. Renal vein length 24. Renal vein diameter /= 16 mm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Safety -<br /><br>Serious Adverse Events (SAE): device related SAEs rate through 30 days post<br /><br>index procedure (Refer to definition in Appendix B). Safety data will be<br /><br>collected throughout study period.<br /><br><br /><br>- Feasibility -<br /><br>Technical Success: Successful delivery and deployment of the RVD* Catheter via<br /><br>the RVD* Introducer, on an intention-to-treat basis, adequate function during<br /><br>device operation and successful retrieval of the RVD* Catheter and RVD*<br /><br>Introducer.<br /><br>Procedural Success: Technical Success and the absence of device-related SAE<br /><br>through hospital discharge.</p><br>