Heart FailureCAPNCT01242891
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
A study testing EXCOR® Pediatric Ventricular Assist Device in people with Heart Failure and Cardiomyopathies, run by Berlin Heart, Inc.
Trial summary
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Heart Failure, Cardiomyopathies
- What is being tested?
- EXCOR® Pediatric Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 1 day to 16 years
- All sexes
- Child
Who may be able to join
- Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class IV for patients <= 6 years) heart failure refractory to optimal medical therapy, and has met at least one of the following criteria:
- INTERMACS profile status 1 or 1A, i.e. critical cardiogenic shock (low BP unresponsive to support), compromised end organ perfusion, < 24 hour survival without mechanical support; may be due to Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) (1A) OR
- INTERMACS profile status or 2A (i.e progressive decline): not in imminent danger, but worsening despite optimal inotropic therapy; may be due to VT/VF (2A) AND at least one of the following criteria: Decline in renal functions, Decline in nutritional status, Decline in mobility/ambulation
- OR
- Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical circulatory support device OR
- Unable to separate from cardiopulmonary bypass
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- Listed (UNOS status 1A or equivalent) for cardiac transplantation
- Two-ventricle circulation, including cardiomypathy, repaired structural heart disease or acquired heart disease
- Age 0 to 16 years
- Weight >= 3 kg and <= 60 kg
- Legal guardian (and patient if age-appropriate) understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure.
Who cannot join
- Support on ECMO for >= 10 days
- Cardiopulmonary resuscitation (CPR) duration >= 30 minutes within 48 hours of implantation
- Body weight < 3.0 kg or Body Surface Area > 1.5 m2
- Presence of mechanical aortic valve
- Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy
- Evidence of intrinsic hepatic disease
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- Evidence of intrinsic renal disease
- Evidence of intrinsic pulmonary disease
- Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for fluid removal)
- Moderate or severe aortic and/or pulmonic valve insufficiency
- Apical VSD or other compromise that is technically challenging to repair at implant
- Documented heparin induced thrombocytopenia (HIT)
- Documented coagulopathy
- Hematologic disorder
- Active Infection within 48 hours of implant (positive blood culture or White Blood Cell count >15,000 and fever > 38 degrees C)
- Documented Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- Evidence of recent life-limiting malignant disease
- Stroke within 30 days prior to enrollment
- Psychiatric or behavioral disease
- Currently participating in another IDE or IND trial
- Patient is pregnant or nursing
About this study
Official title: A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
Read the detailed description
The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).
- Conditions
- Heart Failure, Cardiomyopathies
- Being tested
- EXCOR® Pediatric Ventricular Assist Device
- Keywords
- Ventricular Assist Device, Pediatric Ventricular Assist Device
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCOR® Pediatric Ventricular Assist DeviceDevice
Also called Berlin Heart, EXCOR®, EXCOR® Pediatric, EXCOR® Pediatric VAD
Extracorporeal Ventricular Assist Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Berlin Heart, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- All Previous IDE Sites, Principal investigator, See IDE Clinical Trials Listing for IDE Study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242891
- Sponsor's protocol ID
- EXCOR® Continued Access
- Acronym
- CAP
- Status last verified
- Mar 2012
- First submitted
- 16 Nov 2010
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.
- ClinicalTrials.gov ID
- NCT01242891
- Acronym / sponsor ID
- CAP / EXCOR® Continued Access
- Conditions
- Heart Failure, Cardiomyopathies
- Keywords
- Ventricular Assist Device, Pediatric Ventricular Assist Device
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Berlin Heart, IncIndustry (pharma, biotech, devices)
- First posted
- 17 Nov 2010 (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 main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
Detailed description
The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).
Study design
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (11 listed)
- Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class IV for patients <= 6 years) heart failure refractory to optimal medical therapy, and has met at least one of the following criteria:
- INTERMACS profile status 1 or 1A, i.e. critical cardiogenic shock (low BP unresponsive to support), compromised end organ perfusion, < 24 hour survival without mechanical support; may be due to Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) (1A) OR
- INTERMACS profile status or 2A (i.e progressive decline): not in imminent danger, but worsening despite optimal inotropic therapy; may be due to VT/VF (2A) AND at least one of the following criteria: Decline in renal functions, Decline in nutritional status, Decline in mobility/ambulation
- OR
- Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical circulatory support device OR
Key exclusion criteria (21 listed)
- Support on ECMO for >= 10 days
- Cardiopulmonary resuscitation (CPR) duration >= 30 minutes within 48 hours of implantation
- Body weight < 3.0 kg or Body Surface Area > 1.5 m2
- Presence of mechanical aortic valve
- Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy
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 |
|---|---|---|
| EXCOR® Pediatric Ventricular Assist DeviceAlso: Berlin Heart, EXCOR®, EXCOR® Pediatric, EXCOR® Pediatric VADExtracorporeal Ventricular Assist Device | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Berlin Heart IncLink provided by the sponsor.
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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.
All Previous IDE Sites principal investigator
See IDE Clinical Trials Listing for IDE Study
Questions about this trial
What is this clinical trial studying?
A study testing EXCOR® Pediatric Ventricular Assist Device in people with Heart Failure and Cardiomyopathies, run by Berlin Heart, Inc.
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 11 inclusion and 21 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 6 Mar 2012.