- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01543022
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
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- 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
- Name: Carol Loring
- Phone Number: 781-646-1595
- Email: cloring@abiomed.com
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Not yet recruiting
- St. Paul's Hospital
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Principal Investigator:
- Anson Cheung, MD
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Ontario
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London, Ontario, Canada, N6A 5A5
- Not yet recruiting
- London Health Sciences Center, University Hospital
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Principal Investigator:
- Mackenzie A Quantz, MD
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
- Recruiting
- Royal Victoria Hospital
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Principal Investigator:
- Renzo Cecere, MD
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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
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
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:
- 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.
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 |
Intervention / Treatment |
---|---|
Experimental: Symphony system
|
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 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
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
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
November 1, 2011
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
February 27, 2012
First Submitted That Met QC Criteria
March 1, 2012
First Posted (Estimate)
March 2, 2012
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Chronic Heart Failure
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Maastricht University Medical CenterUniversity College Dublin; RWTH Aachen University; Queen's University, BelfastCompletedChronic Heart FailureNetherlands, Germany, Ireland, United Kingdom
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Lithuanian University of Health SciencesCompletedHeart Failure | Chronic Heart Failure | Congestive Heart Failure | Right Ventricular FailureLithuania
-
Zensun Sci. & Tech. Co., Ltd.RecruitingChronic Heart FailureChina
-
Jordan Cardio Vascular Research GroupRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureJordan
-
University Hospital, Clermont-FerrandHospices Civils de Lyon; University Hospital, Grenoble; Hôpital de la Croix-Rousse and other collaboratorsRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureFrance
-
University of Roma La SapienzaUnknownChronic Heart Failure | Decompensated Heart Failure | Morality
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AquaPass Medical Ltd.CompletedChronic Heart FailureIsrael
-
University Medicine GreifswaldDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)RecruitingChronic Heart FailureGermany
-
Zensun Sci. & Tech. Co., Ltd.Terminated
Clinical Trials on Symphony
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LivaNovaCompletedSinus Node Dysfunction | Bradycardia-Tachycardia Syndrome | Paroxysmal Atrioventricular BlockUnited Kingdom, France, Germany, Belgium, Italy
-
International Spine Study Group FoundationDePuy SynthesRecruitingCervical DeformityUnited States
-
Imperative Care, Inc.RecruitingCardiovascular Diseases | Vascular Diseases | Embolism | Thrombosis | Thromboembolism | Acute Pulmonary Embolism | Thrombus; Embolism | Emboli, PulmonaryUnited States
-
LivaNovaCompletedSinus Node Dysfunction | Brady Tachy SyndromeUnited States, France, Belgium, Germany, United Kingdom, Italy, Monaco, Spain
-
Sorin Group CanadaCompletedAny Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA GuidelinesCanada
-
Medela AGCompleted
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LivaNovaCompletedAssess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.Italy, France, Spain, United States, Germany, United Kingdom
-
Sunnybrook Health Sciences CentreSunnybrook Research Institute; Arrayus Technologies Inc.Active, not recruiting
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Yale UniversityCompletedLabor Pain | Labor Long | Breast Pumping | Induced; Birth | Lactation InducedUnited States
-
Aroa Biosurgery LimitedProfessional Education and Research InstituteRecruitingDiabetic Foot | Foot Ulcer | Wound Healing | Chronic Foot UlcerUnited States