Phase 4
N=72
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02836652 ↗Enrolled (actual)
72
Serious AEs
72.3%
Results posted
Oct 2020
Primary outcome: Primary: Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant — 12; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HeartMate II (HMII) (Device); Warfarin (Drug); acetylsalicylic acid (ASA) therapy (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant |
12; 15 | — |
| PRIMARY Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant |
4; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
- Subject is ≥ 50 years of age
- Subject is receiving the HM II as their first LVAD
- Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).
Exclusion Criteria
- Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices
- Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
- Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
- Subjects in whom heart transplantation is expected in ≤ 6 months
- Subjects with a known ASA allergy
Data sourced from ClinicalTrials.gov (NCT02836652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.