Clinical trial NCT00878527: Safety and Performance Evaluation of CircuLite Synergy
Official title: Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Partial Circulatory Assist
NYHA Class IIIb
NYHA Class IV
Ventricular Assist Device
VAD
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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 criteria: 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

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: 3 months
Secondary outcomes:
measure: Change in hemodynamics
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Berlin
country: Germany
facility: German Heart Centre Berlin
city: Cologne
country: Germany
facility: Heart Center Cologne University Hospital
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Hannover
country: Germany
facility: Medical School Hannover
city: Leipzig
country: Germany
facility: Heart Centre University Leipzig
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Milan
country: Italy
facility: Humanitas Clinical and Research Center
city: Bratislava
country: Slovakia
facility: National Institute of Cardiovascular Diseases Bratislava
city: Harefield
country: United Kingdom
facility: Harefield Hospital
Study officials:
References:
citation: 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.
citation: 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.