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Safety and Performance Evaluation of CircuLite Synergy

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT00878527
Collaborator
(none)
63
Enrollment
11
Locations
1
Arm
127
Actual Duration (Months)
5.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: CircuLite Synergy Pocket Circulatory Assist Device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
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 :
Jun 29, 2007
Actual Primary Completion Date :
Jan 29, 2018
Actual Study Completion Date :
Jan 29, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety - Adverse Events [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Belgium 3000
    2 German Heart Centre Berlin Berlin Germany 10179
    3 Heart Center Cologne University Hospital Cologne Germany 50937
    4 University Hospital Freiburg Freiburg Germany 79106
    5 Hannover Medical School Hannover Germany 30625
    6 Medical School Hannover Hannover Germany 30625
    7 Heart Centre University Leipzig Leipzig Germany 04289
    8 University Hospital Muenster Muenster Germany 48149
    9 Humanitas Clinical and Research Center Milan Italy 20089
    10 National Institute of Cardiovascular Diseases Bratislava Bratislava Slovakia 83348
    11 Harefield Hospital Harefield United Kingdom UB9 6JH

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT00878527
    Other Study ID Numbers:
    • CircuLite CRP-001
    First Posted:
    Apr 9, 2009
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Medtronic Cardiac Rhythm and Heart Failure
    Heart Failure
    Partial Circulatory Assist
    NYHA Class IIIb
    NYHA Class IV
    Ventricular Assist Device
    VAD
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Sep 18, 2018