HEARTAssist 5

STUDY IDENTIFIER:

HEARTAssist 5

CONDITION:

Heart Failure; Cardiac Failure; Congestive Heart Failure; Heart Failure Left-Sided

CONTACT INFO:

Kari Thomas   |   Kari.m.Thomas@allina.com   |   612-863-7493

DESCRIPTION:

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.

CRITERIA LIST/ QUALIFICATIONS:

  • Body Surface Area (BSA) ≥ 1.2 m2.
  • Cardiac transplant candidate.
  • LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
  • Patient is NYHA Class IV.
 

INVESTIGATORS:

Benjamin Sun, MD

SPONSORS:

ReliantHeart Inc.

STATUS:

Open/Enrolling