Recruiting
Phase 1
Phase 2

CPD

Sponsor:

Abiomed Inc.

Code:

NCT01543022

Conditions

Chronic Heart Failure

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Symphony

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

Study Details

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 ID

NCT01543022

Start date

Nov, 2011

Status verified date

May, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Symphony system

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.

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.

Primary outcome measure

  • Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention [ Time Frame: hospital discharge or 30 days of support, whichever is longer ]

Central Contacts and Locations

Central contacts

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Principal Investigator:

Renzo Cecere, MD

More Information

Sponsor

Abiomed Inc.

Last update posted

May 3, 2013

Last verified

May, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abiomed Inc. on 2013-05-03.