Clinical Evaluation of the TRVD™ System in ADHF

NCT03621436 | Terminated

• 1 other identifier: DRD00202, DRD00208, DRD00214
• Study Type: interventional
• Target: 13
• Locations: 3 countries
• Sites: 3

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.

Conditions

Acute Heart Failure; Congestive Heart Failure; Heart Failure, Congestive

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Initial performance (effectiveness of renal venous pressure reduction)

  Up to 24 hours

Study Arms (1)

TRVD Therapy

EXPERIMENTAL

Device: TRVD Therapy

Interventions

TRVD Therapy DEVICE

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.

TRVD Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Magenta Medical Ltd.: lead

Study Sites (3)

OLV-Hospital Aalst, Belgium

Aalst, 9300, Belgium

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Zemun Clinical Hospital Center

Belgrade, Serbia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: August 8, 2018
• Study Start: August 7, 2015
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CR (1); BE (1); SE (1)