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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart device called the Jarvik 2000 VAS, which assists in pumping blood for individuals with severe heart failure. It compares the Jarvik 2000 to the HeartMate II, a device already approved for use. The trial aims to determine if the Jarvik 2000 is safe and effective for those who are not candidates for a heart transplant and have experienced severe heart failure for at least 45 out of the last 60 days. Ideal participants are those whose severe heart failure has not improved with other treatments. As an unphased trial, this study allows patients to contribute to important research that could lead to new treatment options for severe heart failure.

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 prior data suggests that the Jarvik 2000 VAS is safe for heart failure patients?

Research has shown that the Jarvik 2000 VAS (ventricular assist system) is generally well-tolerated by patients. One study found that it effectively aids individuals with severe heart failure, reporting acceptable rates of death and illness among users. Early experiences with the Jarvik 2000 have been positive, particularly for those with serious heart conditions, suggesting the device is relatively safe. However, as with any medical treatment, risks or side effects may still occur. Prospective participants should discuss these with a healthcare provider when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for heart failure, which often includes medications, lifestyle changes, or devices like the HeartMate II VAS, the Jarvik 2000 VAS offers a unique approach with its post-auricular cable design. This innovative design allows the device to be less intrusive and potentially more comfortable for patients, as it connects through the skin behind the ear rather than through the abdomen. Researchers are excited about this treatment because its novel delivery method could enhance quality of life and ease of use for patients living with heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that the Jarvik 2000 Ventricular Assist System (VAS), one of the treatments studied in this trial, can improve heart function in people with severe heart failure. In earlier studies, patients using the Jarvik 2000 demonstrated better heart performance and lived longer than those who did not use it. The device aids the left side of the heart, the main part that pumps blood, by boosting blood flow throughout the body. Early results suggest that the Jarvik 2000 effectively helps the heart recover and strengthen. Overall, this treatment has shown promise in supporting people with serious heart conditions. Participants in this trial may receive either the Jarvik 2000 or the HeartMate II, another ventricular assist system, to compare their effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert Jarvik, MD

Principal Investigator

Jarvik Heart, Inc. SPONSOR

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35421002/

The Jarvik 2000 Left Ventricular Assist Device The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial ... MeSH terms. Female; Heart Failure* / ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01627821

Evaluation of the Jarvik 2000 Left Ventricular Assist System ... Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, ...

3. ahajournals.org ahajournals.org/doi/10.1161/01.cir.0000018167.47314.af

Initial Clinical Experience With the Jarvik 2000 Implantable ... Cardiopulmonary Performance Among Heart Failure Patients Before and After Left Ventricular Assist Device Implantation, JACC: Heart Failure, 12, 1, (117-129) ...

4. cardiolinkgroup.com cardiolinkgroup.com/wp-content/uploads/2018/06/2014-Clinical-results-with-Jarvik-2000-axial-flow-Yoshioka-D._1.pdf

Clinical results with Jarvik 2000 axial flow left ventricular ... Between 2005 and 2010, nine patients with severe heart failure underwent implantation of the Jarvik 2000 VAD. D. Yoshioka (&) 4 G. Matsumiya 4 K. Toda 4 T.

5. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.98.15.1568

Jarvik 2000 Heart | Circulation Background—Mechanical bridge to left ventricular recovery is an emerging strategy for the treatment of heart failure. We sought to validate the use of a new ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0735109702018557

Implantation of the permanent jarvik-2000 left ventricular ... Our early experience with the permanent Jarvik-2000 LVAD has been encouraging. It can be used in patients with dilative or restrictive disease.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25048655/

Clinical Results With Jarvik 2000 Axial Flow Left ... We found that the Jarvik 2000 with pin bearing could support patients with end-stage heart failure with acceptable mortality and morbidity rates.