Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-03-01 @ 10:48 PM
Study NCT ID:
NCT03781258
Status:
UNKNOWN
Last Update Posted:
2020-08-04
First Post:
2018-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)
Sponsor:
Institute for Clinical and Experimental Medicine
Organization:
Study Overview
Official Title:
Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: