Trials / Completed
CompletedNCT04069156
The ARIES HeartMate 3 Pump IDE Study
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 628 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
Detailed description
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LVAD Implant | Subjects will undergo Heartmate 3 LVAD implant prior to randomization |
| DRUG | Aspirin 100mg | Subjects will be randomized to either Placebo or Aspirin post implant. |
| DRUG | Placebo oral tablet | Subjects will be randomized to either Placebo or Aspirin post implant |
Timeline
- Start date
- 2020-07-14
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
- First posted
- 2019-08-28
- Last updated
- 2025-03-27
- Results posted
- 2025-03-27
Locations
51 sites across 9 countries: United States, Australia, Austria, Canada, Czechia, France, Italy, Kazakhstan, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04069156. Inclusion in this directory is not an endorsement.