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

NCT01543022 | Unknown Phase 1 DMC

• 1 other identifier: 184916
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention

  The trial will primarily look at patient safety defined as proportion of composite Major Adverse Events (MAE) up to hospital discharge or 30 days of CPD support, whichever is longer.

  hospital discharge or 30 days of support, whichever is longer

Study Arms (1)

Symphony system

EXPERIMENTAL

Device: Symphony; Procedure: The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker

Interventions

Symphony DEVICE

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.

Symphony system

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

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.

Symphony system

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association Class IIIB or IV heart failure despite optimal medical therapy, including ACE inhibitors, beta blockers, IV diuretics and pressors
• Left Ventricular Ejection Fraction \< 40%.
• Patient is not a candidate for conventional catheter-based or surgical intervention such as valve intervention or coronary artery bypass surgery.
• Patient is not currently a candidate for heart transplantation or placement of a left ventricular assist device (LVAD) as bridge to heart transplantation due to co-morbidities. Patients may become a candidate for these options if they have improvement on the device due to improved cardiac output.
• Patients have exhausted all approved surgical and medical therapies as determined by a heart failure cardiologist and a surgeon with expertise in heart failure.
• Patient has been evaluated by a multi-disciplinary research team and felt to be a suitable candidate for a research study. The final decision regarding the patient's candidacy for research will remain with the attending cardiologist and heart surgeon.
• Improved hemodynamics on device support will allow for potential for physical rehabilitation.
• Signed Informed Consent, or oral informed consent with written confirmation by uninvolved third party
• Age of subject at least 19 years

You may not qualify if:

• High likelihood of death during the current hospitalization (as judged by the attending physician) and condition other than heart failure that would limit survival to less than two years.
• Require mechanical ventilation.
• Failure to wean from IABP, Impella, ECMO or other mode of circulatory support.
• Complex arrhythmias that negatively impact the effectiveness of counter pulsation.
• Dependency on high dose inotropes.
• Cerebrovascular accident or TIA within the previous 3 months.
• Contraindication to anticoagulation medication such as Heparin, Coumadin, Aspirin and Plavix.
• Presence of hypercoaguable state or history of idiopathic venous or arterial thrombosis.
• Severe calcification in the target vessel that will preclude insertion of the Symphony device.
• Moderate to severe aortic insufficiency (2+ or more).
• Ongoing systemic infection defined as two of the following:
• WBC \> 12,500
• positive blood culture
• fever
• Abnormal pre-albumin (\< 13mg/dL), or albumin (\< 3.0 mg/dl)

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (3)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

London Health Sciences Center, University Hospital

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Central Study Contacts

Carol Loring

CONTACT

781-646-1595; cloring@abiomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

CA (3)