Safety and Performance Evaluation of CircuLite Synergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878527
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : September 18, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CircuLite Synergy Pocket Circulatory Assist Device Not Applicable

Detailed Description:
The CircuLite Synergy Pocket Circulatory Assist Device is an implantable miniature, mixed-flow blood pump designed o provide partial left ventricular support in patients with advanced heart failure. Treatment for this patient population currently include lifestyle changes, medicines, transcatheter interventions and surgery, including implantation of mechanical ventricular assist devices (VADs); most of the currently available VADs require highly invasive, high-risk surgical procedures to implant due to large device size, and are therefore generally limited to use in patients with terminal heart failure. The Synergy pump is intended for treatment of patients with New York Heart Association (NYHA) Class III and IV heart failure; it is expected that the pump will provide these patients with 2-3 L/min of additional blood flow, giving adequate cardiac support to increase exercise tolerance and improve patients' quality of life. The pump's small size will allow it to be implanted in a less surgically invasive procedure than used with previous VADs, which should result in a reduction of perioperative morbidity. The device wil be implanted in a left atrial to subclavian artery bypass with the pump being located in the infraclavicular fossa like a pacemaker.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
Actual Study Start Date : June 29, 2007
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : January 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment with the pump
Treatment with the CircuLite Synergy Pocket Circulatory Assist Device
Device: CircuLite Synergy Pocket Circulatory Assist Device
Goal of successful implantation and follow-up for at least three months
Other Names:
  • CircuLite
  • CircuLite Synergy
  • CircuLite Micro pump
  • CircuLite Synergy Partial Circulatory Assist Device

Primary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: 3 months ]
    Evaluation of the incidences of device failure or malfunction, adverse events associated with device use, surgical complications with device implant, and demonstration that the device provides adequate circulatory support in advanced HF patients.

Secondary Outcome Measures :
  1. Change in hemodynamics [ Time Frame: 3 months ]
    Evaluation of changes across time in hemodynamics, exercise tolerance, neurohormones, quality of life, functional capacity and ventricular function to determine the incidence of worsening HF in patients while supported by the CircuLite Synergy Device.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Maximum tolerable medical therapy including ACE inhibitors and Beta Blockers
  • NYHA Class III or IV despite maximal tolerable medical therapy
  • Ambulatory (inpatient or outpatient)
  • Patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
  • Life expectancy of at least 6 months without full VAD support

Exclusion Criteria:

  • Age >75 years
  • Exercise tolerance limited by factors other than heart failure
  • Presence of intra-atrial thrombus
  • Clinically significant right heart failure
  • Serum creatinine >/= 2.5 mg/dl or any dialysis in previous 3 months
  • Evidence of intrinsic hepatic disease
  • Previous episode of resuscitated sudden death without subsequent treatment with AICD
  • Subclavian artery stenosis
  • Low platelet count, INR that cannot be corrected prior to implant or contraindication to anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878527

UZ Leuven
Leuven, Belgium, 3000
German Heart Centre Berlin
Berlin, Germany, 10179
Heart Center Cologne University Hospital
Cologne, Germany, 50937
University Hospital Freiburg
Freiburg, Germany, 79106
Hannover Medical School
Hannover, Germany, 30625
Medical School Hannover
Hannover, Germany, 30625
Heart Centre University Leipzig
Leipzig, Germany, 04289
University Hospital Muenster
Muenster, Germany, 48149
Humanitas Clinical and Research Center
Milan, Italy, 20089
National Institute of Cardiovascular Diseases Bratislava
Bratislava, Slovakia, 83348
United Kingdom
Harefield Hospital
Harefield, United Kingdom, UB9 6JH
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT00878527     History of Changes
Other Study ID Numbers: CircuLite CRP-001
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Partial Circulatory Assist
Ventricular Assist Device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases