DOT HeartMate 3 Study

NCT04974684 | Completed Results FDA Device

• 1 other identifier: A-21-23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.

Conditions

LVAD (Left Ventricular Assist Device) Thrombosis

Keywords

HeartMate 3; LVAD (Left Ventricular Assist Device); NOAC

Outcome Measures

Primary Outcomes (1)

• Evaluation of Hemocompatibility Related Adverse Events During Apixaban Use With the HeartMate 3 LVAS

  Evaluation survival free of major hemocompatibility related adverse events (HRAEs). Major HRAEs include: * Stroke (ischemic/hemorrhagic) * Pump thrombosis * Severe bleeding (see Appendix II) * Peripheral arterial thromboembolic events Comparison of HRAEs in apixaban and control group per protocol. Separate analysis in patients randomized to receive aspirin and no-aspirin within the apixaban group as specified in protocol.

  6 months

Secondary Outcomes (1)

• Evaluation of Adverse Events Defined by INTERMACS Definitions

  Through study completion, an average of 1 year.

Study Arms (2)

Interventional group

EXPERIMENTAL

This study group will contain 30 patients that will be stratified further by 1:1 randomization to 2 groups of 15 patients - one group will be given only apixaban 5mg twice a day, the second group will be given apixaban 5mg twice a day and aspirin 100mg per day.

Device: HeartMate 3; Drug: Apixaban

Control group

NO INTERVENTION

This study group will contain 15 patients that will by treated following standard anticoagulation protocol (Warfarin INR 2-3 + aspirin 100mg/day).

Interventions

HeartMate 3 DEVICE

Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.

Interventional group

Apixaban DRUG

Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.

Interventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has been implanted with HeartMate 3 LVAS
• The patient is, at a minimum, 3 months post HeartMate 3 implant
• The patient is stable, ambulatory, and has been discharged home
• The patient provides written informed consent before any clinical investigation related procedure

You may not qualify if:

• Non-compliance with anticoagulation and antiplatelet medication, in the opinion of the investigator
• Weight ≤ 60 kgs. or age ≥ 80 years
• Poor kidney function with serum creatinine ≥ 221umol/L or creatinine clearance \< 0.042 mL/s, or the need for chronic renal replacement therapy
• Total bilirubin \> 43 umol/L, shock liver, or biopsy-proven liver cirrhosis
• Absence of an informed consent
• Presence of any mechanical prosthetic valve or any ancillary circulatory assist device system (other than the HM3)
• Recent history of cardioembolic stroke
• Hemodynamically significant carotid arteries stenosis (documented by imaging investigation not older than 12 months)
• Need for antiplatelet therapy for reasons other than LVAD therapy
• Major HRAE event after HeartMate 3 index hospitalization discharge
• Known history of hyper- or hypo- coagulable disorder
• Anti-phospholipid syndrome positive patients with documented history of thrombotic/thromboembolic events
• Known hypersensitivity or allergy to apixaban or aspirin
• The patient is involved in another interventional study or any study that could potentially affect the functioning of the HM3 LVAD or the therapeutic effect of any of the study anticoagulants (warfarin, apixaban or aspirin), or could potentially confound the study results
• The patient is currently pregnant, breastfeeding, or intending to get pregnant during the study

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

MeSH Terms

Conditions

Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Our study is limited by its single-center design, small numbers and short follow-up.

Results Point of Contact

• Title: Dr. Zuzana Tucanova
• Organization: IKEM Prague

zuzana.tucanova@ikem.cz

+420 776292211

Study Officials

• Ivan Netuka, MD, PhD

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Cardiovascular Surgery Department

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 23, 2021
• Study Start: April 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Locations

CZ (1)