Evaluation of the Jarvik 2000 Left Ventricular Assist System for heart failure treatment

Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study

This study is testing if the Jarvik 2000 heart pump can help people with severe heart failure live longer and avoid serious problems compared to another heart pump.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jarvik Heart, Inc. (industry)
• Locations: 1 site (New York, New York)
• Trial ID: NCT01627821 on ClinicalTrials.gov

What this trial studies

This clinical investigation focuses on patients with end-stage heart failure who are not eligible for cardiac transplantation. It is a multi-center, randomized, open-label study comparing the Jarvik 2000 Left Ventricular Assist System (LVAS) with an active control group receiving the Thoratec HeartMate II LVAS. The study aims to assess the effectiveness of the Jarvik 2000 LVAS in terms of survival rates and freedom from serious complications over a two to three-year period. The primary endpoints include survival rates and the occurrence of device-related complications.

Who should consider this trial

Good fit: Ideal candidates are patients with late-stage heart failure in NYHA Class IIIb or IV who are not eligible for cardiac transplantation.

Not a fit: Patients with conditions that limit survival to less than three years or those with a history of cardiac transplantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced heart failure who are not candidates for transplantation.

How similar studies have performed: Other studies have shown success with similar left ventricular assist devices, indicating a promising approach in treating advanced heart failure.

Eligibility criteria

Inclusion Criteria:

1. Cardiac transplantation ineligible.
2. Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
3. Cardiac Index \< 2.2 L / min / m2
4. LVEF = 25% or less
5. 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.
6. BSA \> 1.2 m2 and \< 2.5 m2.

Exclusion Criteria:

1. History of cardiac transplantation or left ventricular reduction procedure.
2. Clinical conditions, other than heart failure, which could limit survival to less than three years.
3. Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
4. Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
5. 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.
6. Chronic immunosuppression.

Where this trial is running

New York, New York

• Columbia/NY Presbyterian — New York, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Robert Jarvik, MD

Conditions: Heart Failure