Cardiovascular Diseases, Heart Failure
Conditions
Keywords
Mechanical circulatory support, Anti-thrombotic monotherapy
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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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.
Interventions
DRUGWarfarin
Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.
Sponsors
Abbott
Institute for Clinical and Experimental Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model 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single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent and anticoagulation with warfarin will be withdrawn.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 endpoint will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.
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 * a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events and pump malfunction * 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 speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see Appendix III); Clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination
Exclusion criteria
* absence of an informed consent * presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch) * presence of any other ancillary circulatory assist device system * known history of major thrombotic event e.g. deep vein thrombosis (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 evidenced by transoesophageal echocardiography * any other clinical indication for a use of long-term anticoagulation using a vitamin K antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival free of a pump malfunction due to thrombosis or any ischemic stroke | 180 days | To determine survival free of a pump malfunction due to thrombosis or any ischemic stroke at 90-days (primary safety end point) and at 180-days (primary efficacy end point) in patients implanted with HeartMate 3 LVAS after transition to a single antithrombotic with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 180 days | Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions. |
Countries
Czechia
Outcome results
None listed