Cardiovascular Diseases, Heart Failure
Conditions
Keywords
Single anti-thrombotic therapy, Mechanical circulatory support
Brief summary
The purpose of this study is to obtain a single-center safety and feasibility data on patients managed with a single anti-thrombotic therapy and the incidence of thrombotic adverse events associated with HeartMate 3 LVAS therapy.
Detailed description
Patients implanted with the HeartMate 3 LVAS in whom at least 6 months reduced anticoagulation therapy (INR range 1.5-1.9 along with antiplatelet therapy) has been accomplished safely will be screened for participation in the study. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) and anticoagulation with warfarin will be removed. 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 endpoint will be analyzed at 90 days after initiation of the single antiplatelet therapy.
Interventions
DRUGWarfarin
Removal of anticoagulation with warfarin
Sponsors
Abbott
Institute for Clinical and Experimental Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy * 6 months or more on reduced anti-coagulation regimen (target INR 1.5-1.9) free of thromboembolic and thrombotic complications * evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after the speed optimization without a significant progression of heart failure based on a biomarker and complex clinical assessment follow-up
Exclusion criteria
* absence of an informed consent * presence of any prosthetic valve * known history of major thrombotic event e.g. DVT * known history of stroke * left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant * evidence of any intracardiac thrombus * any clinical indication for use of long-term warfarin anticoagulation (e.g. known genetic thrombotic mutation, malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival free rate of thromboembolic events | 90 days | Determination of survival free of thromboembolic events (i.e. pump thrombosis or any ischemic stroke) using only a single antithrombotic therapy with Acetylsalicylic Acid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 90 days | Adverse events rates per INTERMACS definitions. |
Countries
Czechia
Outcome results
None listed