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LVAD (Left Ventricular Assist Device) ThrombosisPhase 3NCT07471139

SWITCH: Apixaban vs Vitamin K in HM3

A Phase 3 study testing Warfarin and Apixaban in people with LVAD (Left Ventricular Assist Device) Thrombosis and Heart Failure, run by Columbia University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Warfarin and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
No sites listed yet
Study dates
Aug 2026to Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants will have HeartMate3 LVAD implanted > 3 months before enrollment
  • ≥ 18 years old
  • Treated with WARFARIN SODIUM
  • Participant must provide written informed consent prior to any clinical investigation related procedure
  • In female participants of childbearing capability, not currently pregnant and on appropriate contraception

Who cannot join

  • Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
  • Known allergy to Apixaban
  • Bridge to transplant
  • Severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) <20
  • History of major bleeding event with subsequent reduction of INR goal to < 1.8
  • Apixaban dose reduction criteria (Age ≥80 years, weight ≤60 kg, creatinine ≥1.5 mg/dL)
  • Aortic root thrombus

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ilan Richter, MD contact

3322098345

ir2498@cumc.columbia.edu

About this study

Official title: The SWITCH Trial: A Randomized Controlled Study of Apixaban Versus Vitamin K Antagonists in Patients With HeartMate 3 Left Ventricular Assist Devices

This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.

Read the detailed description

Heart failure is a global epidemic, and Left Ventricular Assist Devices (LVADs) - particularly the HeartMate 3 (HM3) - are increasingly used due to their survival benefit over medical therapy. Despite advances, hemocompatibility-related adverse events (HRAEs) like thrombosis and bleeding remain significant causes of morbidity and mortality.

Direct Oral Anticoagulants (DOACs) have shown superiority over warfarin in heart failure patients, with lower rates of embolic and intracranial bleeding. Reduced-dose DOACs also appear to reduce major bleeding without increasing thrombotic risk. However, data on their use in LVAD patients is limited, consisting mainly of case reports, small series, retrospective analyses, and a few small randomized clinical trials.

Some reports suggest apixaban may reduce bleeding in high-risk LVAD patients, though cases of pump thrombosis and stroke have occurred. Early studies comparing DOACs to warfarin in patients with HeartMate II (HMII), HeartWare™ HVAD™ System, and The Abbott HeartMate 3 (HM3) show no significant differences in outcomes, with a trend toward less bleeding with apixaban. Two small randomized clinical trials in HM3 patients (The DOAC LVAD Study and The DOT-HM3 Study) found similar results.

This prospective, randomized, controlled, non-inferiority trial will evaluate the safety and efficacy of apixaban versus vitamin K antagonists in HM3 patients more than 3 months post-implant.

Being tested
Warfarin, Apixaban
Medical subject headings
Thrombosis, Heart Failure, Hemorrhage, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WarfarinDrug

    Also called COUMADIN, warfarin sodium

    Warfarin dose titrated for an International Normalized Ratio (INR) >= 1.8

  • ApixabanDrug

    Also called Eliquis

    Apixaban 5 mg bid (twice a day)

Study groups in NCT07471139
Study groupRoleWhat they receive
WarfarinActive comparatorParticipants will take warfarin, dose titrated for an INR >= 1.8
Receives: Drug: Warfarin
ApixabanExperimentalParticipants wil take apixaban 5 mg bid
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival free of major hemocompatibility related adverse event

    Major Hemocompatibility Related Adverse Event: Stroke, Pump Thrombosis, major non surgical Bleeding (moderate or severe), Arterial Peripheral Thromboembolism. Rates will be compared between study groups.

    Measured: 12 months

Secondary outcomes (7)

  1. Non-surgical Major Hemorrhagic Events

    Rates will be compared between study groups.

    Measured: 12 months

  2. Non-surgical Major Thrombotic Events

    Rates will be compared between study groups.

    Measured: 12 months

  3. Survival

    Rates will be compared between study groups.

    Measured: 12 months

  4. Stroke Rates

    Rates will be compared between study groups.

    Measured: 12 months

  5. Pump Thrombosis Rates

    Rates will be compared between study groups.

    Measured: 12 months

  6. Bleeding Rates

    Rates will be compared between study groups.

    Measured: 12 months

  7. Rates of listing for Heart Transplant

    Rates will be compared between study groups.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07471139
Sponsor's protocol ID
AAAV9532
Status last verified
Aug 2026
First submitted
24 Feb 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Netuka I, Tucanova Z, Ivak P, Gregor S, Kolesar DM, Marek T, Melenovsky V, Binova J, Dorazilova Z, Hegarova M, Podolec M, Riha H, Connors JM, Mehra MR. A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study. Circulation. 2024 Aug 6;150(6):509-511. doi: 10.1161/CIRCULATIONAHA.124.069726. Epub 2024 Apr 9. No abstract available.

    PubMed 38594972

  • Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7.

    PubMed 38795110

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Warfarin and Apixaban in people with LVAD (Left Ventricular Assist Device) Thrombosis and Heart Failure, run by Columbia University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ilan Richter, MD (3322098345, ir2498@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival free of major hemocompatibility related adverse event (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471139, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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