MedTrace Logo

Clinical Evaluation of the TRVD™ System in ADHF

NCT03621436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-08-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Magenta Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2019-04-30
Completion
2019-05-31

Countries

  • Belgium
  • Croatia
  • Serbia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621436 on ClinicalTrials.gov