Heart FailureNCT00878527
Safety and Performance Evaluation of CircuLite Synergy
A study testing CircuLite Synergy Pocket Circulatory Assist Device in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 5 countries.
Trial summary
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CircuLite Synergy Pocket Circulatory Assist Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 29 Jun 2007to 29 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Germany7 sites
German Heart Centre Berlin
Berlin, 10179
Heart Center Cologne University Hospital
Cologne, 50937
University Hospital Freiburg
Freiburg im Breisgau, 79106
Hannover Medical School
Hanover, 30625
Medical School Hannover
Hanover, 30625
Heart Centre University Leipzig
Leipzig, 04289
University Hospital Muenster
Münster, 48149
Slovakia1 site
National Institute of Cardiovascular Diseases Bratislava
Bratislava, 83348
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- CircuLite Synergy Pocket Circulatory Assist Device
- Keywords
- Heart Failure, Partial Circulatory Assist, NYHA Class IIIb, NYHA Class IV, Ventricular Assist Device, VAD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircuLite Synergy Pocket Circulatory Assist DeviceDevice
Also called CircuLite, CircuLite Synergy, CircuLite Micro pump, CircuLite Synergy Partial Circulatory Assist Device
Goal of successful implantation and follow-up for at least three months
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the pump | Experimental | Treatment with the CircuLite Synergy Pocket Circulatory Assist Device Receives: Device: CircuLite Synergy Pocket Circulatory Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Change in hemodynamics
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study start29 Jun 2007
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878527
- Sponsor's protocol ID
- CircuLite CRP-001
- Status last verified
- Sep 2018
- First submitted
- 8 Apr 2009
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17198776Meyns 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.
PubMed 19555845
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
- ClinicalTrials.gov ID
- NCT00878527
- Acronym / sponsor ID
- CircuLite CRP-001
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Partial Circulatory Assist, NYHA Class IIIb, NYHA Class IV, Ventricular Assist Device, VAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2007 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the pump | Experimental | Device: CircuLite Synergy Pocket Circulatory Assist DeviceTreatment with the CircuLite Synergy Pocket Circulatory Assist Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircuLite Synergy Pocket Circulatory Assist DeviceAlso: CircuLite, CircuLite Synergy, CircuLite Micro pump, CircuLite Synergy Partial Circulatory Assist DeviceGoal of successful implantation and follow-up for at least three months | Device | Treatment with the pump |
Primary outcome
Safety - Adverse Events
Time frame: 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.
1 secondary outcome
Change in hemodynamics
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Background: PubMed 17198776Morley 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.
- Derived from this study: PubMed 19555845Meyns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CircuLite Synergy Pocket Circulatory Assist Device in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Belgium, Italy, Slovakia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878527, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.