NCT01543022

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

First in Man Study - a Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the Symphony Device

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter pulsation therapy for up to thirty (30) days to patients with chronic heart failure who have persistent worsening of their condition despite optimal medical therapy. Patients will be in New York Heart Association (NYHA) Class IIIb or IV heart failure and have exhausted all medical or surgical options.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2012-03-02
• Last updated: 2013-05-03

Locations

3 sites across 1 country: Canada