Chronic Heart FailurePhase 1/2SymphonyNCT01543022
Symphony: The Implantable Counter Pulsation Device (CPD) Safety and Feasibility Trial
A Phase 1/2 study testing Symphony and The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker in people with Chronic Heart Failure, run by Abiomed Inc. at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Symphony and The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2011to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association Class IIIB or IV heart failure despite optimal medical therapy, including ACE inhibitors, beta blockers, IV diuretics and pressors
- Left Ventricular Ejection Fraction < 40%.
- Patient is not a candidate for conventional catheter-based or surgical intervention such as valve intervention or coronary artery bypass surgery.
- 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.
- Patients have exhausted all approved surgical and medical therapies as determined by a heart failure cardiologist and a surgeon with expertise in heart failure.
- 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.
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- Improved hemodynamics on device support will allow for potential for physical rehabilitation.
- Signed Informed Consent, or oral informed consent with written confirmation by uninvolved third party
- Age of subject at least 19 years
Who cannot join
- 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.
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- 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:
- WBC > 12,500
- positive blood culture
- fever
- 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:
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
London Health Sciences Center, University Hospital
London, Ontario, N6A 5A5
Mackenzie A Quantz, MD
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Renzo Cecere, MD
- Not yet recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Anson Cheung, MD
About this study
Official title: 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Symphony, The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymphonyDevice
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 pacemakerProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Symphony system | Experimental | Not described Receives: Device: Symphony; Procedure: The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: hospital discharge or 30 days of support, whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543022
- Sponsor's protocol ID
- 184916
- Acronym
- Symphony
- Status last verified
- May 2013
- First submitted
- 27 Feb 2012
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man Study - a Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the Symphony Device
- ClinicalTrials.gov ID
- NCT01543022
- Acronym / sponsor ID
- Symphony / 184916
- Conditions
- Chronic Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symphony system | Experimental | Device: Symphony, Procedure: The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- New York Heart Association Class IIIB or IV heart failure despite optimal medical therapy, including ACE inhibitors, beta blockers, IV diuretics and pressors
- Left Ventricular Ejection Fraction < 40%.
- Patient is not a candidate for conventional catheter-based or surgical intervention such as valve intervention or coronary artery bypass surgery.
- 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.
- Patients have exhausted all approved surgical and medical therapies as determined by a heart failure cardiologist and a surgeon with expertise in heart failure.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymphonyThe 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. | Device | Symphony system |
| The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemakerThe 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. | Procedure or surgery | Symphony system |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Symphony and The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker in people with Chronic Heart Failure, run by Abiomed Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Loring (781-646-1595, cloring@abiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.