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Trial record 63 of 291 for:    warfarin AND anticoagulation

MAGENTUM 1 HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)

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: NCT03078374
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Prof. Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine

Brief Summary:
The purpose of this study is to obtain single-center safety and feasibility data on patients managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse events associated with the HeartMate 3 LVAS therapy.

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

Detailed Description:
Patients with implanted HeartMate 3 device will be bridged with heparin until target International Normalized Ratio (INR) of 2,0 - 3,0 will be reached on anticoagulation therapy with Warfarin. Along with Warfarin, Acetylsalicylic Acid (ASA) will be administered in dose of 100mg per day. Enrollment for the study will take place in 1-6 weeks post implant of HeartMate 3. Low-intensity anticoagulation protocol will be started at 6 weeks after implant. Target INR of 1,5-1,9 will be maintained and ASA will be administered in dose of 100mg per day with adjustments based on VerifyNow testing. Follow up will last for 12 months after HeartMate 3 implantation. Subsequently, the objectives of the study will be analyzed and evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Feasibility Study of Low-intensity Anticoagulation With HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)
Actual Study Start Date : January 11, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Reduced Anticoagulation
Reduced anticoagulation
Drug: Warfarin
Reduced dosage to obtain lower INR range




Primary Outcome Measures :
  1. Survival-free rate of thromboembolic and hemorrhagic events [ Time Frame: 12 months ]
    12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS>3) and hemorrhagic events (major bleeding, hemorrhagic stroke).


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    Adverse Event rates as assessed per INTERMACS definitions.



Information from the National Library of Medicine

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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 an indication
  • data collection for major thrombophilic mutations including anti-phospholipid syndrome and lupus anticoagulant testing prior to low-intensity protocol anticoagulation initiation has been performed
  • patient will be compliant with an anticoagulation management in a judgment of the investigator
  • patient in stable condition with anticipated home discharge

Exclusion Criteria:

  • absence of an informed consent
  • presence of additional MCS e.g. ECMO, RVAD in less than 7 days prior to low- intensity protocol anticoagulation initiation
  • known history of major thrombotic event e.g. DVT
  • presence of other than biological valve prosthesis in aortic position
  • left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
  • hemodynamically significant or symptomatic carotid artery stenosis prior to low-intensity protocol anticoagulation initiation

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): NCT03078374


Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Abbott
Investigators
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Principal Investigator: Ivan Netuka, MD, Ph.D. Institute for Clinical and Experimental Medicine

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Ivan Netuka, MD, Ph.D., Vice Chairman of Cardiac Centre, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03078374     History of Changes
Other Study ID Numbers: Version 2.0
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Reduced anti-coagulation, mechanical circulatory support.
Additional relevant MeSH terms:
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Cardiovascular Diseases
Warfarin
Anticoagulants