Symphony: The Implantable Counter Pulsation Device (CPD) Safety and Feasibility Trial

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

June 30, 2014

Conditions
Chronic Heart Failure
Interventions
DEVICE

Symphony

The Symphony system has been developed for superficial implantation without the need to enter the chest. It allows for complete patient mobility and provides counter pulsation therapy for up to 30 days in hospitalized patients.

PROCEDURE

The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker

The vascular graft is surgically attached (anastomosed) to the subclavian artery. The symphony device is implanted into a pocket below the pectoralis muscle on the anterior chest and attached to the graft. The driveline is tunneled out through the skin and attached to the drive console.

Trial Locations (3)

V6Z 1Y6

NOT_YET_RECRUITING

St. Paul's Hospital, Vancouver

N6A 5A5

NOT_YET_RECRUITING

London Health Sciences Center, University Hospital, London

H3A 1A1

RECRUITING

Royal Victoria Hospital, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abiomed Inc.

INDUSTRY