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Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers

This study has been completed.
Information provided by (Responsible Party):
Dr. Ofer Amir, Clalit Health Services Identifier:
First received: July 29, 2012
Last updated: March 8, 2015
Last verified: March 2015
Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic solution, therefore not causing substantial changes in NaCl concentrations, and the use of peripheral veins makes it feasible to use in out of hospital medical centers, for non compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the hypothesis of this study is that it is feasible for a professional team to effectively use the UF for short courses on non compensated HF patients with low or no response to Diuretics, in a dedicated out of hospital HF center.

Condition Intervention
Heart Failure
Procedure: blood ultrafiltration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers

Resource links provided by NLM:

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers [ Time Frame: 12 months ]
    The propose of the study is to observe the administrative needs of performing the treatment at our specific out-patient clinic. Of note the treatment is already approved including the indication and the place we are doing it so we merely aim to look at administrative and logistic that need to be done.

Enrollment: 38
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heart Failure patients Procedure: blood ultrafiltration

Detailed Description:

The patients will be treated in the LIN Heart Failure Center and will not include population defined in the Exclusion criteria.

Up to 60 patients will be recruited and each one will undergo up to 30 treatments in time intervals defined by the cardiologist according to the clinical needs throughout the duration of the study.

Inclusion duration of every patient will be terminated at the end of the treatment course. No prevention in adding more treatment courses per patient according to clinical needs upon the cardiologist's decision.

Operating the UF system:

During the treatment course two of the patient's peripheral veins will be cannulated. One will be used to draw blood from, and the other will be used to return the blood back in to the patient.

The patient will be administered with Heparin IV, or Clexane SC with an ACT target of 180-200 that will be monitored every 4-6 hours.

Fluid removal rate will be according to the cardiologists discretion and will not exceed 500 ml/hour Patient monitoring - Pulse and BP will be recorded at baseline, after 10 minutes for treatment onset and every 1 hour.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HF patients

Inclusion Criteria:

HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist

Exclusion Criteria:

  1. Age < 18 years
  2. Patient does not fully comprehend the Essence of the study and can not sign the informed consent.
  3. Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.
  4. Presence of Acute MI
  5. CR base values > 3mg/dl
  6. Hemodynamic instability requiring Inotropic agents
  7. HT base values > 45%
  8. Known pregnancy
  9. Presence of contraindication to anticoagulants
  10. Post heart transplant or cardiac assist device implantation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01654926

Lin Clinic
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
  More Information

Responsible Party: Dr. Ofer Amir, Head of the Lin Heart Failure Center, Clalit Health Services Identifier: NCT01654926     History of Changes
Other Study ID Numbers: UF-HF-1
Study First Received: July 29, 2012
Last Updated: March 8, 2015

Keywords provided by Clalit Health Services:
Feasibility of using the FlexFlowTM ultrafiltration pump in a non hospital environment

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 24, 2017