NCT00878527

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable heart-failure

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

10.6 years

First QC Date

April 8, 2009

Last Update Submit

September 17, 2018

Conditions

Heart Failure

Keywords

Heart FailurePartial Circulatory AssistNYHA Class IIIbNYHA Class IVVentricular Assist DeviceVAD

Outcome Measures

Primary Outcomes (1)

  • Safety - Adverse Events

    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.

    3 months

Secondary Outcomes (1)

  • Change in hemodynamics

    3 months

Study Arms (1)

Treatment with the pump

EXPERIMENTAL

Treatment with the CircuLite Synergy Pocket Circulatory Assist Device

Device: CircuLite Synergy Pocket Circulatory Assist Device

Interventions

CircuLite Synergy Pocket Circulatory Assist DeviceDEVICE

Goal of successful implantation and follow-up for at least three months

Also known as: CircuLite, CircuLite Synergy, CircuLite Micro pump, CircuLite Synergy Partial Circulatory Assist Device
Treatment with the pump

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UZ Leuven

Leuven, 3000, Belgium

Location

German Heart Centre Berlin

Berlin, 10179, Germany

Location

Heart Center Cologne University Hospital

Cologne, 50937, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Medical School Hannover

Hanover, 30625, Germany

Location

Heart Centre University Leipzig

Leipzig, 04289, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Humanitas Clinical and Research Center

Milan, 20089, Italy

Location

National Institute of Cardiovascular Diseases Bratislava

Bratislava, 83348, Slovakia

Location

Harefield Hospital

Harefield, UB9 6JH, United Kingdom

Location

Related Publications (2)

  • Morley D, Litwak K, Ferber P, Spence P, Dowling R, Meyns B, Griffith B, Burkhoff D. Hemodynamic effects of partial ventricular support in chronic heart failure: results of simulation validated with in vivo data. J Thorac Cardiovasc Surg. 2007 Jan;133(1):21-8. doi: 10.1016/j.jtcvs.2006.07.037.

    PMID: 17198776BACKGROUND

  • Meyns B, Klotz S, Simon A, Droogne W, Rega F, Griffith B, Dowling R, Zucker MJ, Burkhoff D. Proof of concept: hemodynamic response to long-term partial ventricular support with the synergy pocket micro-pump. J Am Coll Cardiol. 2009 Jun 30;54(1):79-86. doi: 10.1016/j.jacc.2009.04.023.

    PMID: 19555845DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

June 29, 2007

Primary Completion

January 29, 2018

Study Completion

January 29, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

IT(1)BE(1)SL(1)GB(1)DE(7)