Biventricular FailureNCT00614510
SynCardia CardioWest TAH-t Postmarket Surveillance Study
An observational study of Biventricular Failure, run by SynCardia Systems. LLC.
Trial summary
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biventricular Failure
- What is being tested?
- CardioWest temporary Total Artificial Heart (TAH-t)
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Mar 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been or will be implanted with the SynCardia Total Artificial Heart.
Who may be able to join
- The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Who cannot join
- Patients who are not cardiac transplant eligible.
- Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) < 10 cm.
- Patients who cannot be adequately anticoagulated on the TAH-t.
About this study
Official title: The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.
- Conditions
- Biventricular Failure
- Being tested
- CardioWest temporary Total Artificial Heart (TAH-t)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioWest temporary Total Artificial Heart (TAH-t)Device
The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject survival at 30-days and one-year post transplant
Measured: 30-days and one-year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biventricular 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
- Observational
- Observational model
- Cohort
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynCardia Systems. LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack G Copeland, MD, Principal investigator, University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614510
- Sponsor's protocol ID
- PR 05003
- Other IDs
- P030011/S1
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2008
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
- ClinicalTrials.gov ID
- NCT00614510
- Acronym / sponsor ID
- PR 05003
- Conditions
- Biventricular Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- SynCardia Systems. LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Feb 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.
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.
Study design
- Observational model
- Cohort
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been or will be implanted with the SynCardia Total Artificial Heart.
Key inclusion criteria (1 listed)
- The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Key exclusion criteria (3 listed)
- Patients who are not cardiac transplant eligible.
- Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) < 10 cm.
- Patients who cannot be adequately anticoagulated on the TAH-t.
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 |
|---|---|---|
| CardioWest temporary Total Artificial Heart (TAH-t)The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines. | Device | – |
Primary outcome
Subject survival at 30-days and one-year post transplant
Time frame: 30-days and one-year post transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Related trials for Biventricular Failure
Recruiting
BiVACOR® Total Artificial Heart Early Feasibility Study
Heart Failure, Biventricular Failure
Recruiting
CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
Conduction System Pacing, Biventricular Pacing
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.
Jack G Copeland, MD principal investigator
University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Biventricular Failure, run by SynCardia Systems. LLC.
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 3 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: finished, as of the sponsor's last update on 30 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Subject survival at 30-days and one-year post transplant (time frame: 30-days and one-year post transplant). 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 30 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.