Heart FailureNCT01627821
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
A study testing Jarvik 2000 VAS and HeartMate II in people with Heart Failure, run by Jarvik Heart, Inc. at 1 site in United States.
Trial summary
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Jarvik 2000 VAS and HeartMate II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac transplantation ineligible.
- Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
- Cardiac Index < 2.2 L / min / m2
- LVEF = 25% or less
- Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
- BSA > 1.2 m2 and < 2.5 m2.
Who cannot join
- History of cardiac transplantation or left ventricular reduction procedure.
- Clinical conditions, other than heart failure, which could limit survival to less than three years.
- Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
- Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
- Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.
- Chronic immunosuppression.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Columbia/NY Presbyterian
New York, New York, 10032
Yoshifumi Naka, MD PhD, 212-305-0828
About this study
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.
Read the detailed description
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Two year actuarial survival
- Freedom from procedures to repair, or replace the implanted device
- Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Three year survival
- Freedom from the serious adverse event of drive cable or pump pocket infection
- Conditions
- Heart Failure
- Being tested
- Jarvik 2000 VAS, HeartMate II
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarvik 2000 VASDevice
Jarvik 2000 LVAD
HeartMate IIDevice
Also called HM II
HeartMate II LVAD
| Study group | Role | What they receive |
|---|---|---|
| Jarvik 2000 Treatment | Active comparator | Jarvik 2000 VAS, Post-Auricular Cable Receives: Device: Jarvik 2000 VAS |
| HeartMate II Control | Active comparator | HeartMate II VAS Control Receives: Device: HeartMate II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority to Control Group.
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Two year actuarial survival
- Freedom from procedures to repair, or replace the implanted device
- Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Measured: 2 years
Secondary outcomes (2)
Serious adverse events
Serious adverse events
Measured: 2 years
Quality of life measures: Questionnaire
Kansas City Cardiomyopathy Questionnaire. There are 23 items. Scores from 0-100 in which a higher score indicates better quality of life.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startFeb 2013
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
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
- NCT01627821
- Sponsor's protocol ID
- G100124
- Status last verified
- Mar 2024
- First submitted
- 22 Jun 2012
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
- ClinicalTrials.gov ID
- NCT01627821
- Acronym / sponsor ID
- G100124
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Jarvik Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Jun 2012 (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.
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.
Detailed description
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Two year actuarial survival
- Freedom from procedures to repair, or replace the implanted device
- Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Three year survival
- Freedom from the serious adverse event of drive cable or pump pocket infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jarvik 2000 Treatment | Active comparator | Device: Jarvik 2000 VASJarvik 2000 VAS, Post-Auricular Cable |
| HeartMate II Control | Active comparator | Device: HeartMate IIHeartMate II VAS Control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cardiac transplantation ineligible.
- Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
- Cardiac Index < 2.2 L / min / m2
- LVEF = 25% or less
- Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
Key exclusion criteria (6 listed)
- History of cardiac transplantation or left ventricular reduction procedure.
- Clinical conditions, other than heart failure, which could limit survival to less than three years.
- Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
- Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
- Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.
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 |
|---|---|---|
| Jarvik 2000 VASJarvik 2000 LVAD | Device | Jarvik 2000 Treatment |
| HeartMate IIAlso: HM IIHeartMate II LVAD | Device | HeartMate II Control |
Primary outcome
Non-inferiority to Control Group.
Time frame: 2 years
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis. Subject composite success requires the subject to achieve the Effectiveness Endpoint: 1. Two year actuarial survival 2. Freedom from procedures to repair, or replace the implanted device 3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
2 secondary outcomes
Serious adverse events
Time frame: 2 years
Quality of life measures: Questionnaire
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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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 study testing Jarvik 2000 VAS and HeartMate II 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?
The sponsor lists 6 inclusion and 6 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 20 Mar 2024. 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.
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?
Contact Robert Jarvik, MD (212-397-3911, clinical@jarvikheart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority to Control Group. (time frame: 2 years). 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 20 Mar 2024.