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Safety and Performance Evaluation of CircuLite Synergy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878527
First Posted: April 9, 2009
Last Update Posted: February 27, 2017
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.
Information provided by (Responsible Party):
HeartWare, Inc.
April 8, 2009
April 9, 2009
February 27, 2017
June 2007
December 2017   (Final data collection date for primary outcome measure)
Safety - Adverse Events [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00878527 on ClinicalTrials.gov Archive Site
Change in hemodynamics [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Safety and Performance Evaluation of CircuLite Synergy
Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
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
Experimental: Treatment with the pump
Intervention: Device: CircuLite Synergy Pocket Circulatory Assist Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy,   Slovakia,   United Kingdom
 
 
NCT00878527
CircuLite CRP-001
Yes
Not Provided
Not Provided
HeartWare, Inc.
HeartWare, Inc.
Not Provided
Not Provided
HeartWare, Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP