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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symphony system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
Abnormal pre-albumin (< 13mg/dL), or albumin (< 3.0 mg/dl)
A cardiac rhythm that cannot be used to trigger the CPD (sinus rhythm, ventricular or atrial pacing, A-V pacing).
Abnormal bilateral carotid Doppler or CT exam define as > 50% stenosis.
Subclavian artery internal diameter of < 7 mm on Doppler study or CT exam.
Ability to ambulate < 200 metres on a 6 minute walk test.
Any aortic aneurysmal disease.
Active documented HIT.
Presence of mechanical heart valve.
Moderate to severe RV failure.
Severe tricuspid regurgitation.
History of major psychiatric illness.
End-organ dysfunction including:
Chest X-ray to rule out pulmonary pathology that increases the risk of need for treatment prior to device implant.
BMI > 40 kg/ m2.
Active participation in another clinical trial that may interfere with this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol Loring | Contact | 781-646-1595 | cloring@abiomed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Not yet recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| 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. |
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| London Health Sciences Center, University Hospital | Not yet recruiting | London | Ontario | N6A 5A5 | Canada |
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| Royal Victoria Hospital | Recruiting | Montreal | Quebec | H3A 1A1 | Canada |
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