Safety and Performance Evaluation of CircuLite Synergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by CircuLite, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CircuLite, Inc.
ClinicalTrials.gov Identifier:
NCT00878527
First received: April 8, 2009
Last updated: June 6, 2011
Last verified: June 2011

April 8, 2009
June 6, 2011
June 2007
October 2011   (final data collection date for primary outcome measure)
Safety - Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00878527 on ClinicalTrials.gov Archive Site
Change in hemodynamics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Synergy Pocket Circulatory Assist Device
  • 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.
 
Recruiting
30
December 2011
October 2011   (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
Both
18 Years to 75 Years
No
Contact: Marion Carrigan 201-478-7650 mcarrigan@circulite.net
Belgium,   Germany
 
NCT00878527
CircuLite CRP-001
Yes
Marion Carrigan, Clinical Research Manager, CircuLite, Inc.
CircuLite, Inc.
Not Provided
Study Chair: Dan Burkhoff, MD, PhD CircuLite, Inc.
CircuLite, Inc.
June 2011

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