- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878527
Safety and Performance Evaluation of CircuLite Synergy
September 17, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Berlin, Germany, 10179
- German Heart Centre Berlin
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Cologne, Germany, 50937
- Heart Center Cologne University Hospital
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Freiburg, Germany, 79106
- University Hospital Freiburg
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Hannover, Germany, 30625
- Hannover Medical School
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Hannover, Germany, 30625
- Medical School Hannover
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Leipzig, Germany, 04289
- Heart Centre University Leipzig
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Muenster, Germany, 48149
- University Hospital Muenster
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Milan, Italy, 20089
- Humanitas Clinical and Research Center
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Bratislava, Slovakia, 83348
- National Institute of Cardiovascular Diseases Bratislava
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Harefield, United Kingdom, UB9 6JH
- Harefield Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment with the pump
Treatment with the CircuLite Synergy Pocket Circulatory Assist Device
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Goal of successful implantation and follow-up for at least three months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety - Adverse Events
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in hemodynamics
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2007
Primary Completion (Actual)
January 29, 2018
Study Completion (Actual)
January 29, 2018
Study Registration Dates
First Submitted
April 8, 2009
First Submitted That Met QC Criteria
April 8, 2009
First Posted (Estimate)
April 9, 2009
Study Record Updates
Last Update Posted (Actual)
September 18, 2018
Last Update Submitted That Met QC Criteria
September 17, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CircuLite CRP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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