Safety and Performance Evaluation of CircuLite Synergy
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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 |
- Safety - Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- 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 2011 |
| Estimated Primary Completion Date: | October 2011 (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:
|
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 |
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| Contact: Marion Carrigan | 201-478-7650 | mcarrigan@circulite.net |
| Belgium | |
| Catholic University Hospital | Recruiting |
| Leuven, Belgium | |
| Contact: Bart Meyns, MD, PhD bart.meyns@uz.kuleuven.ac.be | |
| Principal Investigator: Bart Meyns, MD, PhD | |
| Germany | |
| Cologne University Hospital | Recruiting |
| Cologne, Germany | |
| Contact: Thorsten Wittwer, MD thorsten.wittwer@uk-koeln.de | |
| Principal Investigator: Thorsten Wittwer, MD | |
| University of Freiburg Hospital | Recruiting |
| Freiburg, Germany | |
| Contact: Christian Schlensak, MD christian.schlensak@uniklinik-freiburg.de | |
| Principal Investigator: Christian Schlensak, MD | |
| Hannover Medical School | Recruiting |
| Hannover, Germany | |
| Contact: Andre Simon, MD simon.andre@mh-hannover.de | |
| Principal Investigator: Andre Simon, MD | |
| University of Muenster | Recruiting |
| Muenster, Germany | |
| Contact: Stefan Klotz, MD stefan.klotz@ukmuenster.de | |
| Principal Investigator: Stefan Klotz, MD | |
| Study Chair: | Dan Burkhoff, MD, PhD | CircuLite, Inc. |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marion Carrigan, Clinical Research Manager, CircuLite, Inc. |
| ClinicalTrials.gov Identifier: | NCT00878527 History of Changes |
| Other Study ID Numbers: | CircuLite CRP-001 |
| Study First Received: | April 8, 2009 |
| Last Updated: | June 6, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by CircuLite, 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 May 22, 2013