Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781258
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Prof. Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiovascular Diseases Drug: Warfarin Not Applicable

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therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn.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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Anit-thrombotic monotherapy
Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).
 Drug: Warfarin
Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survival free of a pump malfunction due to thrombosis or any ischemic stroke [ Time Frame: 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 Outcome Measures :
  1. Adverse Events [ Time Frame: 180 days ]
    Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781258


Locations
Layout table for location information
Czechia
Institute for Clinical and Experimental Medicine
Prague, Prague 4, Czechia, 14021
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Abbott
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Prof. Ivan Netuka, MD, Ph.D., Chairman of the Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03781258    
Other Study ID Numbers: Version 1.0
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine:
Mechanical circulatory support
Anti-thrombotic monotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Warfarin
Anticoagulants