Antithrombotic Treatment for Heart Failure Patients
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Recruiting
Phase 4
Interventional Study
Bleeding
Clot Blood
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 128 (estimated)
- Sponsor
- Columbia University · Other
Who this trial is looking for
This trial is looking for adults with severe heart failure who have a HeartMate3 device placed for over 3 months. Participants will be assigned to different treatment groups to test the safety of a specific blood-thinning regimen without aspirin.
Are You a Good Fit for This Trial?
You may be able to join if
- I have a HeartMate3 device implanted for more than 3 months.
- I am over 18 years old.
- I am currently being treated with aspirin and a vitamin K antagonist.
- I will provide written consent to participate.
You may not be able to join if
- I am required to take other blood-thinning medications for other conditions.
- I am participating in another clinical trial involving a heart device.
- I have other health issues that may affect my participation.
- I am pregnant or not using contraception.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant will have HeartMate3 LVAD implanted \> 3 months before enrollment.
* \>18 years old
* Treated with aspirin and VKA
* Participant must provide written informed consent prior to any clinical investigation-related procedure
Exclusion Criteria:
* Investigator-mandate…
Contacts