Safety and Performance Evaluation of CircuLite Synergy

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878527
• Other study ID #: CircuLite CRP-001
• Status: Completed
• Phase: N/A
• Start date: June 29, 2007
• Est. completion date: January 29, 2018

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 29, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CircuLite Synergy Pocket Circulatory Assist Device
Goal of successful implantation and follow-up for at least three months

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Germany	German Heart Centre Berlin	Berlin
Germany	Heart Center Cologne University Hospital	Cologne
Germany	University Hospital Freiburg	Freiburg
Germany	Hannover Medical School	Hannover
Germany	Medical School Hannover	Hannover
Germany	Heart Centre University Leipzig	Leipzig
Germany	University Hospital Muenster	Muenster
Italy	Humanitas Clinical and Research Center	Milan
Slovakia	National Institute of Cardiovascular Diseases Bratislava	Bratislava
United Kingdom	Harefield Hospital	Harefield

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Slovakia,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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