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

May 1, 2013 updated by: Abiomed Inc.

First in Man Study - a Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the Symphony Device

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Not yet recruiting
        • St. Paul's Hospital
        • Principal Investigator:
          • Anson Cheung, MD
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Not yet recruiting
        • London Health Sciences Center, University Hospital
        • Principal Investigator:
          • Mackenzie A Quantz, MD
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Recruiting
        • Royal Victoria Hospital
        • Principal Investigator:
          • Renzo Cecere, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Symphony system
Device: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention
Time Frame: hospital discharge or 30 days of support, whichever is longer
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abiomed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 184916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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