RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2013-02

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01627821

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Robert Jarvik, MD

CONTACT

212-397-3911

clinical@jarvikheart.com

Principal Investigator

Robert Jarvik, MD

STUDY_CHAIR

Jarvik Heart, Inc. SPONSOR

Study Locations (Sites)

Columbia/NY Presbyterian

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Jarvik Heart, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-02

Study Completion Date2025-03

Study Record Updates

Study Start Date2013-02

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Heart Failure

Additional Relevant MeSH Terms

Heart Failure