Status:
COMPLETED
Safety and Performance Evaluation of CircuLite Synergy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00878527
Start Date
June 29 2007
End Date
January 29 2018
Last Update
September 18 2018
Active Locations (11)
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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 im Breisgau, Germany, 79106