Heart FailurePhase 2/3NCT00591799
Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
A Phase 2/3 study testing The Jarvik 2000 Ventricular Assist System in people with Heart Failure, run by Jarvik Heart, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- The Jarvik 2000 Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: (The following are general inclusion criteria; more specific criteria are outlined in the study protocol).
- Transplant listed UNOS status IA or IB patients.
- BSA >1.5 m2 and <2.3 m2.
- Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).
Exclusion Criteria:(The following are general exclusion criteria; more specific criteria are outlined in the study protocol).
- Known risk factors or conditions that would contraindicate LVAD implantation or adversely affect patient survival.
- Evidence of end organ dysfunction.
- Known coagulopathy or contraindication of anticoagulation or antiplatelet agents.
- Systemic infection.
- Malignancies not in remission.
- Current participation in investigational trials with other devices, drugs, or biologic agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System
The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.
Read the detailed description
The Jarvik 2000 Heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. The pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. A vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. The impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven L/minute. At higher speeds the pump can produce 10 L/minute. Power is provided through an abdominal drive line.
- Conditions
- Heart Failure
- Being tested
- The Jarvik 2000 Ventricular Assist System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Jarvik 2000 Ventricular Assist SystemDevice
Also called Jarvik 2000
Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Jarvik 2000 Ventricular Assist System | Experimental | Jarvik 2000 Ventricular Assist System Receives: Device: The Jarvik 2000 Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
Measured: 180 days
Secondary outcomes (1)
Incidence of serious adverse events as events per patient month including infection, stroke, VAD failure, and all serious adverse events. Quality of Life measures - MLHFQ, NYHA class, Neurocognitive assessments.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startApr 2005
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jarvik Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Jarvik, MD, Study chair, Jarvik Heart, Inc. SPONSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591799
- Sponsor's protocol ID
- G000058
- Status last verified
- Sep 2013
- First submitted
- 26 Dec 2007
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Selzman CH, Feller ED, Walker JC, Sheridan BC, Silvestry SC, Daly RC, Anyanwu AC, Madigan D, Liu PY, Frazier OH, Jorde UP, Griffith BP. The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial. ASAIO J. 2023 Feb 1;69(2):174-182. doi: 10.1097/MAT.0000000000001750. Epub 2022 Apr 13.
PubMed 35421002
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System
- ClinicalTrials.gov ID
- NCT00591799
- Acronym / sponsor ID
- G000058
- Conditions
- Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jarvik Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Jan 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 the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.
Detailed description
The Jarvik 2000 Heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. The pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. A vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. The impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven L/minute. At higher speeds the pump can produce 10 L/minute. Power is provided through an abdominal drive line.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jarvik 2000 Ventricular Assist System | Experimental | Device: The Jarvik 2000 Ventricular Assist SystemJarvik 2000 Ventricular Assist System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| The Jarvik 2000 Ventricular Assist SystemAlso: Jarvik 2000Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria. | Device | Jarvik 2000 Ventricular Assist System |
Primary outcome
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
Time frame: 180 days
1 secondary outcome
Incidence of serious adverse events as events per patient month including infection, stroke, VAD failure, and all serious adverse events. Quality of Life measures - MLHFQ, NYHA class, Neurocognitive assessments.
Time frame: 180 days
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 27 Sep 2013.
- Derived from this study: PubMed 35421002Selzman CH, Feller ED, Walker JC, Sheridan BC, Silvestry SC, Daly RC, Anyanwu AC, Madigan D, Liu PY, Frazier OH, Jorde UP, Griffith BP. The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial. ASAIO J. 2023 Feb 1;69(2):174-182. doi: 10.1097/MAT.0000000000001750. Epub 2022 Apr 13.
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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.
Robert Jarvik, MD study chair
Jarvik Heart, Inc. SPONSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing The Jarvik 2000 Ventricular Assist System in people with Heart Failure, run by Jarvik Heart, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00591799, which also lists 1 linked publication.
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 27 Sep 2013.