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

NCT ID: NCT01543022

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Symphony system

Group Type: EXPERIMENTAL

Symphony

Intervention Type: 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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. New York Heart Association Class IIIB or IV heart failure despite optimal medical therapy, including ACE inhibitors, beta blockers, IV diuretics and pressors

2. Left Ventricular Ejection Fraction < 40%.

3. Patient is not a candidate for conventional catheter-based or surgical intervention such as valve intervention or coronary artery bypass surgery.

4. 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.

5. Patients have exhausted all approved surgical and medical therapies as determined by a heart failure cardiologist and a surgeon with expertise in heart failure.

6. 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.

7. Improved hemodynamics on device support will allow for potential for physical rehabilitation.

8. Signed Informed Consent, or oral informed consent with written confirmation by uninvolved third party

9. Age of subject at least 19 years

Exclusion Criteria

1. 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.

2. Require mechanical ventilation.

3. Failure to wean from IABP, Impella, ECMO or other mode of circulatory support.

4. Complex arrhythmias that negatively impact the effectiveness of counter pulsation.

5. Dependency on high dose inotropes.

6. Cerebrovascular accident or TIA within the previous 3 months.

7. Contraindication to anticoagulation medication such as Heparin, Coumadin, Aspirin and Plavix.

8. Presence of hypercoaguable state or history of idiopathic venous or arterial thrombosis.

9. Severe calcification in the target vessel that will preclude insertion of the Symphony device.

10. Moderate to severe aortic insufficiency (2+ or more).

11. Ongoing systemic infection defined as two of the following:

• WBC > 12,500
• positive blood culture
• fever

12. Abnormal pre-albumin (< 13mg/dL), or albumin (< 3.0 mg/dl)

13. A cardiac rhythm that cannot be used to trigger the CPD (sinus rhythm, ventricular or atrial pacing, A-V pacing).

14. Abnormal bilateral carotid Doppler or CT exam define as > 50% stenosis.

15. Subclavian artery internal diameter of < 7 mm on Doppler study or CT exam.

16. Ability to ambulate < 200 metres on a 6 minute walk test.

17. Any aortic aneurysmal disease.

18. Active documented HIT.

19. Presence of mechanical heart valve.

20. Moderate to severe RV failure.

21. Severe tricuspid regurgitation.

22. History of major psychiatric illness.

23. End-organ dysfunction including:

• renal failure defined as serum Cr > 2.5 mg/dl,
• liver dysfunction defined as bilirubin 2X normal, or elevated INR with no anticoagulation,
• respiratory failure defined as FEV1 < 50% predicted.

24. Chest X-ray to rule out pulmonary pathology that increases the risk of need for treatment prior to device implant.

25. BMI > 40 kg/ m2.

26. Active participation in another clinical trial that may interfere with this trial.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

London Health Sciences Center, University Hospital

London, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Carol Loring

Role: CONTACT

cloring@abiomed.com

781-646-1595

Other Identifiers

184916

Identifier Type: -

Identifier Source: org_study_id