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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627821
• Other study ID #: G100124
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Jarvik Heart, Inc.
• Contact: Robert Jarvik, MD
• Phone: 212-397-3911
• Email: clinical[@]jarvikheart.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Jarvik 2000 VAS
Jarvik 2000 LVAD
• HeartMate II
HeartMate II LVAD

Locations

Country	Name	City	State
United States	Columbia/NY Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jarvik Heart, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serious adverse events	Serious adverse events	2 years
Secondary	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