Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the Abiomed Impella device
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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator John Stulak, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials