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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiovascular Diseases||Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Reduced dosage to obtain lower INR range
- 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).
- Adverse Events [ Time Frame: 12 months ]Adverse Event rates as assessed per INTERMACS definitions.
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
|Principal Investigator:||Ivan Netuka, MD, Ph.D.||Institute for Clinical and Experimental Medicine|