Clinical trial NCT01543022: Symphony: The Implantable Counter Pulsation Device (CPD) Safety and Feasibility Trial
Official title: First in Man Study - a Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the Symphony Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Heart Failure
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention
timeFrame: hospital discharge or 30 days of support, whichever is longer
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Center, University Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
References: