Trials / Unknown
UnknownNCT03781258
Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)
Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Institute for Clinical and Experimental Medicine · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.
Detailed description
Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Warfarin | Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal. |
Timeline
- Start date
- 2018-11-23
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2018-12-19
- Last updated
- 2020-08-04
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT03781258. Inclusion in this directory is not an endorsement.