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

• Sponsor: Jarvik Heart, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT01627821
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 129.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Jarvik 2000 VAS; Device: HeartMate II	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Non-inferiority to Control Group. [2 years]

   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

Secondary Outcome Measures

1. Serious adverse events [2 years]

   Serious adverse events

2. Quality of life measures: Questionnaire [2 years]

   Kansas City Cardiomyopathy Questionnaire. There are 23 items. Scores from 0-100 in which a higher score indicates better quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia/NY Presbyterian	New York	New York	United States	10032

Sponsors and Collaborators

• Jarvik Heart, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jarvik Heart, Inc.
• ClinicalTrials.gov Identifier: NCT01627821
• Other Study ID Numbers: G100124
• First Posted: Jun 26, 2012
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jarvik Heart, Inc.: Heart Failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Mar 31, 2022