RecruitingNot ApplicableNCT03238690

LVAD Conditioning for Cardiac Recovery

Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery

Sponsor

STAVROS G DRAKOS

Enrollment

100 participants

Start Date

Jun 23, 2017

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

The purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD speed is reduced gradually in order to increase the work load of the heart. Multiple previous studies have shown that interventions like this may improve heart function and give patients the opportunity for a better quality of life.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant
Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)

Exclusion Criteria2

Neither the subject nor the subject's representative is willing to provide written consent for participation
Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase

Interventions

DEVICEControlled Cardiac Reloading through LVAD Speed Adjustment

LVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant.