Severe Biventricular End Stage Heart DiseaseNCT00669357
AbioCor Implantable Replacement Heart
A study testing Abiocor Implantable Replacement Heart in people with Severe Biventricular End Stage Heart Disease, run by Abiomed Inc..
Trial summary
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Severe Biventricular End Stage Heart Disease
- What is being tested?
- Abiocor Implantable Replacement Heart
- 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 Up to 75 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.
Who cannot join
- Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.
About this study
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
- Being tested
- Abiocor Implantable Replacement Heart
- Keywords
- End stage heart disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiocor Implantable Replacement HeartDevice
Replacement of heart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Biventricular End Stage Heart DiseaseStudies 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
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669357
- Sponsor's protocol ID
- H040006
- Status last verified
- May 2013
- First submitted
- 25 Apr 2008
- Last updated
- 3 May 2013
- Results posted
- No
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
- AbioCor Implantable Replacement Heart
- ClinicalTrials.gov ID
- NCT00669357
- Acronym / sponsor ID
- H040006
- Keywords
- End stage heart disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- First posted
- 30 Apr 2008 (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.
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
Study design
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.
Key exclusion criteria (1 listed)
- Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.
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 |
|---|---|---|
| Abiocor Implantable Replacement HeartReplacement of heart | 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 3 May 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Abiocor Implantable Replacement Heart in people with Severe Biventricular End Stage Heart Disease, run by Abiomed 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 1 inclusion and 1 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.
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 3 May 2013.