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

NCT ID: NCT01627821

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2025-03-31

Brief Summary

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.

Detailed Description

Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Two year actuarial survival

2. Freedom from procedures to repair, or replace the implanted device

3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up

Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Three year survival

2. Freedom from the serious adverse event of drive cable or pump pocket infection

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jarvik 2000 Treatment

Jarvik 2000 VAS, Post-Auricular Cable

Group Type: ACTIVE_COMPARATOR

Jarvik 2000 VAS

Intervention Type: DEVICE

Jarvik 2000 LVAD

HeartMate II Control

HeartMate II VAS Control

Group Type: ACTIVE_COMPARATOR

HeartMate II

Intervention Type: DEVICE

HeartMate II LVAD

Interventions

Jarvik 2000 VAS

Jarvik 2000 LVAD

Intervention Type: DEVICE

HeartMate II

HeartMate II LVAD

Intervention Type: DEVICE

Other Intervention Names

HM II

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jarvik Heart, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Jarvik, MD

Role: STUDY_CHAIR

Jarvik Heart, Inc. SPONSOR

Locations

Columbia/NY Presbyterian

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert Jarvik, MD

Role: CONTACT

clinical@jarvikheart.com

212-397-3911

Facility Contacts

Yoshifumi Naka, MD PhD

Role: primary

212-305-0828

Other Identifiers

G100124

Identifier Type: -

Identifier Source: org_study_id