Jarvik 2000 VAS for Heart Failure

Overseen By Robert Jarvik, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jarvik Heart, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Thyroid disease, Cardiomyopathy, Amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

350 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should be on Optimal Medical Management (OMM) or other specific treatments. It's best to discuss your current medications with the trial coordinators.

What data supports the idea that Jarvik 2000 VAS for Heart Failure is an effective treatment?

The available research shows that the Jarvik 2000 VAS is effective for heart failure treatment. In one study, 7 out of 10 patients survived to receive a heart transplant after using the device, and they underwent complete physical rehabilitation during support. Another study reported that 8 patients improved significantly, moving from severe heart failure to a much better condition, and 7 of them were able to receive a transplant. The device also helped improve heart function indicators, such as increasing the heart's ability to pump blood by 43% within 48 hours after surgery. Additionally, there were no early deaths during the initial period after surgery in one group of patients. These outcomes suggest that the Jarvik 2000 VAS can effectively support patients with severe heart failure, either as a bridge to transplantation or as a long-term solution. ^{1 2 3 4 5}

What safety data is available for the Jarvik 2000 VAS for heart failure?

The Jarvik 2000 VAS has been evaluated in several studies. In one study, 10 patients received the device, with no early perioperative deaths reported. The average support duration was 81.2 days, ranging from 13 to 214 days, and 7 out of 10 patients survived to transplantation. Another study reported that 7 out of 10 patients underwent transplantation, while 3 died during support. No device thrombosis was observed at explantation. These studies suggest that the Jarvik 2000 can provide effective cardiac support with a reasonable safety profile, although some risks remain. ^{1 2 3 4 6}

Is the Jarvik 2000 VAS a promising treatment for heart failure?

Yes, the Jarvik 2000 VAS is a promising treatment for heart failure. It helps patients with severe heart failure by supporting their heart function, allowing them to wait for a heart transplant or use it as a long-term solution. It can provide a strong blood flow, helping maintain important organ functions like the kidneys and liver. Many patients using it have successfully moved on to heart transplants and regained physical strength during its use. ^{1 3 4 6 7}

What is the purpose of this trial?

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.

Research Team

Robert Jarvik, MD

Principal Investigator

Jarvik Heart, Inc. SPONSOR

Eligibility Criteria

This trial is for adults with severe heart failure who are not eligible for a heart transplant. They must have been in late-stage heart failure for most of the past two months, have a specific body surface area, and be on optimal medical management or other support like IV inotropes. People can't join if they've had certain cardiac procedures, chronic immunosuppression, conditions limiting survival to under three years, intolerance to blood thinners, or sensitivity to bovine products.

Inclusion Criteria

Your body surface area is between 1.2 square meters and 2.5 square meters.

You are not eligible for a heart transplant.

You have had severe heart failure symptoms for most of the past two months.

Exclusion Criteria

You have had a heart transplant or a specific heart surgery to reduce the size of the left ventricle.

You are taking medication that weakens your immune system for a long time.

You have medical conditions, other than heart failure, that may make you unlikely to live for at least three years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Jarvik 2000 LVAS with Post-Auricular Connector or the HeartMate II LVAS for Destination Therapy

2 years

Follow-up

Participants are monitored for survival, device performance, and stroke outcomes

2 years

Extended Follow-up

Participants are monitored for long-term survival and adverse events

3 years

Treatment Details

Interventions

• HeartMate II
• Jarvik 2000 VAS

Trial Overview The study compares two devices designed to help failing hearts: the Jarvik 2000 Left Ventricular Assist System (LVAS) with Post-Auricular Connector and the approved HeartMate II LVAS. It's an open-label trial where participants are randomly assigned one of these treatments as their long-term therapy.

Participant Groups

Group I: HeartMate II Control Active Control 1 Intervention

HeartMate II VAS Control

Group II: Jarvik 2000 Treatment Active Control 1 Intervention

Jarvik 2000 VAS, Post-Auricular Cable

Jarvik 2000 VAS is already approved in United States, European Union for the following indications:

Approved in United States as Jarvik 2000 LVAS for:

• Destination Therapy for end-stage heart failure

Approved in European Union as Jarvik 2000 LVAS for:

• Bridge to transplantation
• Bridge to myocardial improvement
• Destination Therapy for end-stage heart failure

Who Is Running the Clinical Trial?

Jarvik Heart, Inc.

Lead Sponsor

Trials

3

Recruited

510+

Findings from Research

The Jarvik 2000 Heart(TM) is a left ventricular assist device that successfully provided cardiac support with outputs up to 8 L/min in the first group of 10 patients, with no early perioperative deaths and an average support duration of 81.2 days.

Seven out of the 10 patients survived long enough to receive a heart transplant, indicating the device's potential as an effective bridge-to-transplantation option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic management for implantation of the Jarvik 2000 left ventricular assist system. Nussmeier, NA., Probert, CB., Hirsch, D., et al.[2021]

The Jarvik 2000 left ventricular assist system (LVAS) was implanted in 10 heart transplant candidates, showing significant improvements in heart function, including a 43% increase in cardiac index and a 52% decrease in pulmonary capillary wedge pressure within 48 hours post-surgery.

The device demonstrated safety with no thrombosis observed at explantation, and 8 out of 10 patients improved to NYHA class I after rehabilitation, indicating its potential to effectively support patients awaiting heart transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the Jarvik 2000 implantable axial-flow left ventricular assist system. Frazier, OH., Myers, TJ., Gregoric, ID., et al.[2019]

The Jarvik-2000 is a non-pulsatile left ventricular assist device (LVAD) designed for patients with end-stage heart failure, serving as a bridge to transplant or as long-term therapy.

The surgical implantation techniques for the Jarvik-2000 have evolved from traditional methods involving median sternotomy and cardiopulmonary bypass to more minimally invasive approaches, enhancing patient safety and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Jarvik-2000 ventricular assist device implantation: how we do it. Zucchetta, F., Tarzia, V., Bottio, T., et al.[2020]

The Jarvik-2000 left ventricular assist device (LVAD) was successfully implanted in three patients with severe heart failure, showing no major complications and improving cardiac output significantly from 3.7 to 5.9 l/min per m².

All patients experienced improved quality of life post-implantation, indicating that the Jarvik-2000 is a safe and effective long-term treatment option for those with severe heart failure who are not candidates for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of the permanent Jarvik-2000 left ventricular assist device: a single-center experience. Siegenthaler, MP., Martin, J., van de Loo, A., et al.[2019]

The use of left ventricular assist devices (LVADs) has become a standard treatment for patients with end-stage heart failure, particularly for those awaiting organ transplants or who cannot undergo transplantation.

This report highlights the longest documented duration of LVAD support using the Jarvik 2000 device, emphasizing the variability in treatment duration and the potential for LVADs to serve as effective bridges to transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longest reported support (7.5 years) with postauricular type of Jarvik 2000 axial-flow left ventricular assist device. Martin-Suarez, S., Fiorentino, M., Loforte, A., et al.[2022]

The Jarvik-2000 is a permanent left-ventricular-assist device (LVAD) that uses an axial-flow design to support heart function in patients with severe heart failure.

The device is powered through a cable connected to a skull-mounted pedestal, which presents unique surgical considerations and potential complications that need to be managed during implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of the permanent Jarvik-2000 left-ventricular-assist-device: surgical technique. Siegenthaler, MP., Martin, J., Frazier, OH., et al.[2019]

The Jarvik 2000 LVAD was successfully used in 10 patients for up to 214 days, showing its potential as a temporary or permanent support system for patients awaiting heart transplantation.

The device maintained or improved renal and hepatic function in all patients, even those with pre-existing kidney or liver issues, indicating its efficacy in preserving organ function during circulatory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous axial-flow left ventricular assist device (Jarvik 2000) maintains kidney and liver perfusion for up to 6 months. Letsou, GV., Myers, TJ., Gregoric, ID., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Anesthetic management for implantation of the Jarvik 2000 left ventricular assist system. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the Jarvik 2000 implantable axial-flow left ventricular assist system. [2019]

3. China pubmed.ncbi.nlm.nih.gov

The Jarvik-2000 ventricular assist device implantation: how we do it. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Implantation of the permanent Jarvik-2000 left ventricular assist device: a single-center experience. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Longest reported support (7.5 years) with postauricular type of Jarvik 2000 axial-flow left ventricular assist device. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Implantation of the permanent Jarvik-2000 left-ventricular-assist-device: surgical technique. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Continuous axial-flow left ventricular assist device (Jarvik 2000) maintains kidney and liver perfusion for up to 6 months. [2022]