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Safety and Performance Evaluation of CircuLite Synergy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
HeartWare, Inc. Identifier:
First received: April 8, 2009
Last updated: February 23, 2017
Last verified: April 2016
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.

Condition Intervention
Heart Failure
Device: CircuLite Synergy Pocket Circulatory Assist Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device

Further study details as provided by HeartWare, Inc.:

Primary Outcome Measures:
  • Safety - Adverse Events [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Change in hemodynamics [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with the pump 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

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
HeartWare, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: HeartWare, Inc. Identifier: NCT00878527     History of Changes
Other Study ID Numbers: CircuLite CRP-001
Study First Received: April 8, 2009
Last Updated: February 23, 2017

Keywords provided by HeartWare, Inc.:
Heart Failure
Partial Circulatory Assist
Ventricular Assist Device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017