NCT01627821

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

12.1 years

First QC Date

June 22, 2012

Last Update Submit

March 18, 2024

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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: 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

    2 years

Secondary Outcomes (2)

  • Serious adverse events

    2 years

  • Quality of life measures: Questionnaire

    2 years

Study Arms (2)

Jarvik 2000 Treatment

ACTIVE COMPARATOR

Jarvik 2000 VAS, Post-Auricular Cable

Device: Jarvik 2000 VAS

HeartMate II Control

ACTIVE COMPARATOR

HeartMate II VAS Control

Device: HeartMate II

Interventions

Jarvik 2000 VASDEVICE

Jarvik 2000 LVAD

Jarvik 2000 Treatment
HeartMate IIDEVICE

HeartMate II LVAD

Also known as: HM II
HeartMate II Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac transplantation ineligible.
  • Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
  • Cardiac Index \< 2.2 L / min / m2
  • LVEF = 25% or less
  • 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.
  • BSA \> 1.2 m2 and \< 2.5 m2.

You may not qualify if:

  • History of cardiac transplantation or left ventricular reduction procedure.
  • Clinical conditions, other than heart failure, which could limit survival to less than three years.
  • Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
  • Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
  • 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.
  • Chronic immunosuppression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia/NY Presbyterian

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Robert Jarvik, MD

    Jarvik Heart, Inc. SPONSOR

    STUDY CHAIR

Central Study Contacts

Robert Jarvik, MD

CONTACT

212-397-3911clinical@jarvikheart.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 26, 2012

Study Start

February 1, 2013

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)