Clinical Evaluation of the TRVD™ System in ADHF (TRVD)

• ClinicalTrials.gov Identifier: NCT03621436
• Recruitment Status: Terminated
• First Posted: August 8, 2018
• Last Update Posted: August 15, 2019
• Sponsor: Magenta Medical Ltd.
• Information provided by (Responsible Party): Magenta Medical Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Heart Failure; Congestive Heart Failure; Heart Failure, Congestive	Device: TRVD Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)
• Actual Study Start Date: August 7, 2015
• Actual Primary Completion Date: April 2019
• Actual Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: TRVD Therapy	Device: TRVD Therapy; 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.

Outcome Measures

Primary Outcome Measures :

1. Preliminary Safety (device- and procedure-related SAEs) [ Time Frame: 30 days post index procedure ]
   Incidence of device- and procedure-related SAEs
2. 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.
3. 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.

Secondary Outcome Measures :

1. Initial performance (effectiveness of renal venous pressure reduction) [ Time Frame: Up to 24 hours ]
   Invasively assessed renal venous pressure reduction from baseline (in mmHg)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 =/<40%.
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.

Exclusion 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 <9 mg/dL).
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.

Contacts and Locations

Locations

Belgium

OLV-Hospital Aalst, Belgium

Aalst, Belgium, 9300

Croatia

Clinical Hospital Centre Zagreb

Zagreb, Croatia, 10000

Serbia

Zemun Clinical Hospital Center

Belgrade, Serbia

Sponsors and Collaborators

Magenta Medical Ltd.

More Information

• Responsible Party: Magenta Medical Ltd.
• ClinicalTrials.gov Identifier: NCT03621436
• Other Study ID Numbers: DRD00202, DRD00208, DRD00214
• First Posted: August 8, 2018
• Last Update Posted: August 15, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases