Safety and Performance Evaluation of CircuLite Synergy

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.

Detailed Description
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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.

Official Title
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Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CircuLite Synergy Pocket Circulatory Assist Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with the pump<br>Treatment with the CircuLite Synergy Pocket Circulatory Assist Device | Device: CircuLite Synergy Pocket Circulatory Assist Device<br>* Goal of successful implantation and follow-up for at least three months<br>* Other names: CircuLite Synergy Partial Circulatory Assist Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAD, Heart Failure, Partial Circulatory Assist, NYHA Class IIIb, NYHA Class IV, Ventricular Assist Device