Clinical trials: Left Ventricular Assist Devices
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
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.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study.
- Trial name
- Microtech-LVAD (NCT06682910)
- Testing
- Microtech sensor pressure
- Where
- 2 sites in United States, Israel
- Volunteers
- 15 people
- Sponsor
- Microtech Medical Technologies, Ltd
Driveline Heart-assisted Device Related Infection
Driveline Silicone Skin Interface Registry
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a…
- Trial name
- SSI (NCT01577433)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices