Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)

Heart Failure Clinical Trial

Official title:

Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03781258
• Other study ID #: Version 1.0
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 23, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Intervention

Drug:
• Warfarin
Anti-thrombotic monotherapy (ASA)—Warfarin withdrawal.

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague	Prague 4

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Abbott

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11. — View Citation

Netuka I, Ivák P, Tucanová Z, Gregor S, Szárszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival free of a pump malfunction due to thrombosis or any ischemic stroke	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.	180 days
Secondary	Adverse Events	Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions.	180 days

External Links

•   Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the Minimal AnticoaGulation EvaluatioN To aUgment heMocompatibility (MAGENTUM) 1 study
•   Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure