Status and phase
Conditions
Treatments
About
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
Full description
This is a post-market clinical study of HM II patient management practices to be conducted in the United States.
Subjects will be randomized in a 1:1 fashion to the following research drug groups:
The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal