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

Description

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.

Conditions

Heart Failure

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

New York

Columbia/NY Presbyterian, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jarvik Heart, Inc.,

Robert Jarvik, MD, STUDY_CHAIR, Jarvik Heart, Inc. SPONSOR

Study Record Dates

2025-03