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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Jarvik 2000 VAS; Device: HeartMate II

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

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Jarvik, MD; Phone Number: 212-397-3911; Email: clinical@jarvikheart.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia/NY Presbyterian
      • Contact: Yoshifumi Naka, MD PhD; Phone Number: 212-305-0828

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Jarvik 2000 Treatment; Jarvik 2000 VAS, Post-Auricular Cable	Device: Jarvik 2000 VAS; Jarvik 2000 LVAD
Active Comparator: HeartMate II Control; HeartMate II VAS Control	Device: HeartMate II; HeartMate II LVAD; Other Names: HM II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority to Control Group.	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: Two year actuarial survival; Freedom from procedures to repair, or replace the implanted device; Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Serious adverse events	2 years
Quality of life measures: Questionnaire	Kansas City Cardiomyopathy Questionnaire. There are 23 items. Scores from 0-100 in which a higher score indicates better quality of life.	2 years

Collaborators and Investigators

• Sponsor: Jarvik Heart, Inc.
• Investigators: Study Chair: Robert Jarvik, MD, Jarvik Heart, Inc. SPONSOR

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (Estimated): June 26, 2012

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: G100124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO