Safety and Performance Evaluation of CircuLite Synergy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HeartWare, Inc.
ClinicalTrials.gov Identifier:
NCT00878527
First received: April 8, 2009
Last updated: August 21, 2014
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Heart Failure
Device: CircuLite Synergy Pocket Circulatory Assist Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device

Resource links provided by NLM:


Further study details as provided by HeartWare, Inc.:

Primary Outcome Measures:
  • Safety - Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in hemodynamics [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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 Synergy Pocket Circulatory Assist Device
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier: NCT00878527

Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Germany
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
Italy
Humanitas Clinical and Research Center
Milan, Italy, 20089
Slovakia
National Institute of Cardiovascular Diseases Bratislava
Bratislava, Slovakia, 83348
United Kingdom
Harefield Hospital
Harefield, United Kingdom, UB9 6JH
Sponsors and Collaborators
HeartWare, Inc.
Investigators
Study Chair: Dan Burkhoff, MD, PhD CircuLite, Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HeartWare, Inc.
ClinicalTrials.gov Identifier: NCT00878527     History of Changes
Other Study ID Numbers: CircuLite CRP-001
Study First Received: April 8, 2009
Last Updated: August 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by HeartWare, Inc.:
Heart Failure
Partial Circulatory Assist
NYHA Class IIIb
NYHA Class IV
Ventricular Assist Device
VAD

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014