Advanced Heart FailurePhase 4TARGETNCT07081035
Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients
A Phase 4 study testing Warfarin (low-intensity anticoagulation) and Warfarin (standard anticoagulation) in people with Advanced Heart Failure and Left Ventricular Assist Devices, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0) compared to standard anticoagulation therapy (target INR 2.0-3.0) in patients receiving a… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment
- What is being tested?
- Warfarin (low-intensity anticoagulation) and Warfarin (standard anticoagulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2025to Jan 2029
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of the following criteria will be eligible for randomization:
- Adults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.
- Patients who are at least 30 days post-implantation of HeartMate 3 LVAD.
- Patients who have maintained stable anticoagulation therapy with standard INR (2.0-3.0) for at least 30 days post-LVAD implantation.
- Patients or their legal representatives who provide documented informed consent and agree to the study protocol and follow-up schedule.
Who cannot join
- Patients who meet any of the following criteria will be excluded:
- Patients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).
- Patients with a clinically significant stroke or transient ischemic attack (TIA) within the past 6 months.
- Patients with a history of hemorrhagic stroke.
- Patients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).
- Patients with uncontrolled severe hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).
Show all 26Show fewer
- Patients requiring active treatment or surgical intervention for acute LVAD-related thrombosis or hemodynamic instability, or patients who underwent LVAD-related reoperation within the past 30 days.
- Patients with severe renal dysfunction (estimated Glomerular Filtration Rate <15 mL/min) or patients undergoing dialysis.
- Patients with severe liver dysfunction causing coagulation abnormalities or those classified as Child-Pugh class B or C.
- Patients with active bleeding or ongoing hemorrhagic conditions.
- Patients with a high bleeding risk due to:
- Gastrointestinal bleeding or ulcers within the past 6 months.
- Surgery involving the brain, spine, or eyes within the past 6 months.
- Major central nervous system, ophthalmologic, or major open surgical procedures within the past 6 months.
- Presence or suspicion of esophageal varices.
- Arteriovenous malformation or vascular aneurysm.
- Patients who have received thrombolytic therapy for bleeding or thromboembolism within the past 30 days.
- Patients receiving long-term concurrent treatment with other anticoagulants (low molecular weight heparin, NOAC, Fondaparinux, etc.). However, temporary administration for warfarin bridging or heparin use for central venous or arterial catheter maintenance is permitted.
- Patients with persistent anemia (hemoglobin <8 g/dL) or thrombocytopenia (platelet count <50,000/µL) within the past 6 months.
- Patients currently experiencing infective endocarditis.
- Patients with a history of severe allergy or hypersensitivity to warfarin or other anticoagulants used in this study.
- Pregnant or lactating women, or women planning pregnancy during the study period.
- Patients with severe terminal illness with a life expectancy of less than 12 months.
- Patients with alcohol dependence or severe psychiatric conditions hindering study participation.
- Patients unwilling or unable to adhere to the procedures or evaluations required by the study protocol.
- Patients currently participating in another randomized drug or medical device clinical trial who have not yet completed the primary endpoint assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 05505
Min-Seok Kim, MD, PhD, +82-2-3010-5416, msk@amc.seoul.kr
Kitae Kim, MD, +82-2-3010-0987, kktae0416@naver.com
About this study
Official title: A Prospective Study Evaluating the Safety and Efficacy of Lower-Intensity INR Target (1.5-2.0) Versus Standard INR Target (2.0-3.0) in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device (LVAD)
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0) compared to standard anticoagulation therapy (target INR 2.0-3.0) in patients receiving a HeartMate 3 Left Ventricular Assist Device (LVAD).
Despite the demonstrated effectiveness of HeartMate 3 LVAD in reducing thromboembolic complications, standard anticoagulation treatment guidelines recommend maintaining an INR between 2.0 and 3.0, which can lead to a substantial risk of bleeding, especially gastrointestinal (GI) bleeding. Preliminary studies, such as MAGENTUM 1, have indicated potential safety and reduced bleeding events at lower INR targets (1.5-1.9). However, robust evidence through randomized controlled trials is still required.
Read more
The primary objective of the TARGET trial is to determine if low-intensity anticoagulation therapy significantly reduces the incidence of major bleeding and thrombotic events compared to standard therapy within 6 months post-randomization. Secondary objectives include evaluating the safety and hematological complications associated with low-intensity anticoagulation.
The study will enroll adult patients aged ≥19 years who have been stably maintained on standard INR therapy (2.0-3.0) for at least 30 days post-HeartMate 3 LVAD implantation. Participants will be randomized in a 1:1 ratio into two groups: the low-intensity INR group (target INR 1.5-2.0) and the standard INR group (target INR 2.0-3.0). Randomization will be stratified based on the presence of atrial fibrillation.
The primary endpoint is a composite of hemocompatibility-related events, including major bleeding, stroke, and pump thrombosis, occurring within 6 months after randomization, as defined by INTERMACS criteria. Secondary endpoints encompass clinical outcomes such as all-cause mortality, cardiac death, LVAD-related thromboembolic events, stroke, systemic embolism, myocardial infarction, major bleeding incidents, and the rate and number of LVAD-related hospital readmissions and reoperations. Additionally, INR management outcomes, including time in therapeutic range (TTR) and frequency of warfarin dose adjustments, will be assessed.
The trial duration is approximately 36 months, including a 24-month enrollment period, a 6-month follow-up period for each participant, and time allocated for data analysis and reporting. Safety will be rigorously monitored by a Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC), ensuring participant safety and data integrity throughout the study.
This trial aims to provide critical insights that could optimize anticoagulation strategies in LVAD patients, potentially improving patient safety by reducing bleeding risks without compromising thrombotic event protection.
- Conditions
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment, Bleeding Complications, Thrombotic Complications
- Being tested
- Warfarin (low-intensity anticoagulation), Warfarin (standard anticoagulation)
- Keywords
- HeartMate 3 LVAD, Left Ventricular Assist Device, Advanced Heart Failure, Anticoagulation, Warfarin, International Normalized Ratio (INR), Low-intensity Anticoagulation, Major Bleeding, Gastrointestinal Bleeding, Pump Thrombosis, Stroke, Thromboembolism, Hemocompatibility, Randomized Controlled Trial, Safety and Efficacy
- Medical subject headings
- Gastrointestinal Hemorrhage, Stroke, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin (low-intensity anticoagulation)Drug
Low-intensity INR group (Experimental):
Participants will receive anticoagulation therapy with warfarin, aiming for a reduced INR range of 1.5-2.0, which is lower than the current standard recommendation. Warfarin dosing will be regularly adjusted based on INR monitoring throughout the 6-month study period.
Warfarin (standard anticoagulation)Drug
Standard INR group (Active Comparator):
Participants will receive anticoagulation therapy with warfarin, maintaining an INR within the standard therapeutic range of 2.0-3.0. Warfarin dosing adjustments will be made regularly according to standard clinical practice and INR monitoring throughout the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity INR group | Experimental | Intervention: Drug: Warfarin (INR 1.5-2.0) Receives: Drug: Warfarin (low-intensity anticoagulation) |
| Standard INR group | Active comparator | Intervention: Drug: Warfarin (INR 2.0-3.0) Receives: Drug: Warfarin (standard anticoagulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite hemocompatibility-related events
The primary outcome is defined as a composite of hemocompatibility-related events including major bleeding (INTERMACS major bleeding criteria), stroke (ischemic or hemorrhagic), and pump thrombosis occurring within 6 months post-randomization. Events will be centrally adjudicated based on standardized INTERMACS definitions.
Measured: Within 6 months after randomization
Secondary outcomes (18)
All-cause mortality
Incidence of death due to any cause.
Measured: Within 6 months after randomization
Cardiac death
Incidence of death directly attributed to cardiac causes, including heart failure, myocardial infarction, or sudden cardiac death.
Measured: Within 6 months after randomization
LVAD pump thrombosis
Incidence of pump thrombosis as defined by INTERMACS criteria, requiring intervention, replacement, or explantation of the LVAD.
Measured: Within 6 months after randomization
LVAD-related thromboembolism
Incidence of thromboembolic events directly related to LVAD, including embolic strokes or systemic embolisms.
Measured: Within 6 months after randomization
Transient ischemic attack (TIA)
Incidence of transient neurologic deficits lasting less than 24 hours without evidence of acute infarction.
Measured: Within 6 months after randomization
Stroke
Incidence of ischemic or hemorrhagic stroke with clinical neurologic deficits lasting ≥24 hours, as defined by NeuroARC criteria.
Measured: Within 6 months after randomization
Systemic embolism
Incidence of acute systemic embolism affecting major organs or limbs, confirmed by imaging or surgical findings.
Measured: Within 6 months after randomization
Myocardial infarction
Incidence of myocardial infarction diagnosed by typical symptoms, ECG changes, and elevation of cardiac biomarkers.
Measured: Within 6 months after randomization
Major bleeding event
Incidence of major bleeding as defined by INTERMACS major bleeding criteria, including events requiring transfusion or intervention.
Measured: Within 6 months after randomization
Composite (cardiac death, pump thrombosis, thromboembolism)
Combined incidence of cardiac death, LVAD pump thrombosis, and LVAD-related thromboembolic events.
Measured: Within 6 months after randomization
Composite (cardiac death, thrombosis, stroke, embolism, MI)
Combined incidence of cardiac death, LVAD pump thrombosis, stroke, systemic embolism, and myocardial infarction.
Measured: Within 6 months after randomization
Composite (stroke, embolism, TIA, MI)
Combined incidence of stroke, systemic embolism, transient ischemic attack, and myocardial infarction.
Measured: Within 6 months after randomization
Composite (death, stroke, embolism, TIA, MI)
Combined incidence of all-cause mortality, stroke, systemic embolism, transient ischemic attack, and myocardial infarction.
Measured: Within 6 months after randomization
LVAD-related readmission
Incidence and frequency of hospital readmissions directly related to LVAD management or complications.
Measured: Within 6 months after randomization
LVAD-related reoperation
Incidence and frequency of surgical reoperations directly related to LVAD complications or device malfunction.
Measured: Within 6 months after randomization
Time in therapeutic range (TTR)
Proportion of time patients' INR values remain within the predefined therapeutic target range.
Measured: Within 6 months after randomization
Out-of-range INR proportion
Proportion of INR measurements falling outside the predefined therapeutic target range.
Measured: Within 6 months after randomization
Warfarin dose adjustments
Number of warfarin dose adjustments required to maintain target INR range.
Measured: Within 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Seok Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081035
- Sponsor's protocol ID
- AMC_2025_2573
- Acronym
- TARGET
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11.
PubMed 29655662Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.
PubMed 28146651Desai SR, Hwang NC. 2023 ISHLT Guidelines for Mechanical Circulatory Support. J Cardiothorac Vasc Anesth. 2023 Dec;37(12):2419-2422. doi: 10.1053/j.jvca.2023.07.044. Epub 2023 Aug 8. No abstract available.
PubMed 37659882Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
PubMed 27959709Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.
PubMed 29526139
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Safety and Efficacy of Lower-Intensity INR Target (1.5-2.0) Versus Standard INR Target (2.0-3.0) in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device (LVAD)
- ClinicalTrials.gov ID
- NCT07081035
- Acronym / sponsor ID
- TARGET / AMC_2025_2573
- Conditions
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment, Bleeding Complications, Thrombotic Complications
- Keywords
- HeartMate 3 LVAD, Left Ventricular Assist Device, Advanced Heart Failure, Anticoagulation, Warfarin, International Normalized Ratio (INR), Low-intensity Anticoagulation, Major Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0) compared to standard anticoagulation therapy (target INR 2.0-3.0) in patients receiving a HeartMate 3 Left Ventricular Assist Device (LVAD).
Despite the demonstrated effectiveness of HeartMate 3 LVAD in reducing thromboembolic complications, standard anticoagulation treatment guidelines recommend maintaining an INR between 2.0 and 3.0, which can lead to a substantial risk of bleeding, especially gastrointestinal (GI) bleeding. Preliminary studies, such as MAGENTUM 1, have indicated potential safety and reduced bleeding events at lower INR targets (1.5-1.9). However, robust evidence through randomized controlled trials is still required.
The primary objective of the TARGET trial is to determine if low-intensity anticoagulation therapy significantly reduces the incidence of major bleeding and thrombotic events compared to standard therapy within 6 months post-randomization. Secondary objectives include evaluating the safety and hematological complications associated with low-intensity anticoagulation.
The study will enroll adult patients aged ≥19 years who have been stably maintained on standard INR therapy (2.0-3.0) for at least 30 days post-HeartMate 3 LVAD implantation. Participants will be randomized in a 1:1 ratio into two groups: the low-intensity INR group (target INR 1.5-2.0) and the standard INR group (target INR 2.0-3.0). Randomization will be stratified based on the presence of atrial fibrillation.
The primary endpoint is a composite of hemocompatibility-related events, including major bleeding, stroke, and pump thrombosis, occurring within 6 months after randomization, as defined by INTERMACS criteria. Secondary endpoints encompass clinical outcomes such as all-cause mortality, cardiac death, LVAD-related thromboembolic events, stroke, systemic embolism, myocardial infarction, major bleeding incidents, and the rate and number of LVAD-related hospital readmissions and reoperations. Additionally, INR management outcomes, including time in therapeutic range (TTR) and frequency of warfarin dose adjustments, will be assessed.
The trial duration is approximately 36 months, including a 24-month enrollment period, a 6-month follow-up period for each participant, and time allocated for data analysis and reporting. Safety will be rigorously monitored by a Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC), ensuring participant safety and data integrity throughout the study.
This trial aims to provide critical insights that could optimize anticoagulation strategies in LVAD patients, potentially improving patient safety by reducing bleeding risks without compromising thrombotic event protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity INR group | Experimental | Drug: Warfarin (low-intensity anticoagulation)Intervention: Drug: Warfarin (INR 1.5-2.0) |
| Standard INR group | Active comparator | Drug: Warfarin (standard anticoagulation)Intervention: Drug: Warfarin (INR 2.0-3.0) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet all of the following criteria will be eligible for randomization:
- Adults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.
- Patients who are at least 30 days post-implantation of HeartMate 3 LVAD.
- Patients who have maintained stable anticoagulation therapy with standard INR (2.0-3.0) for at least 30 days post-LVAD implantation.
- Patients or their legal representatives who provide documented informed consent and agree to the study protocol and follow-up schedule.
Key exclusion criteria (26 listed)
- Patients who meet any of the following criteria will be excluded:
- Patients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).
- Patients with a clinically significant stroke or transient ischemic attack (TIA) within the past 6 months.
- Patients with a history of hemorrhagic stroke.
- Patients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin (low-intensity anticoagulation)Low-intensity INR group (Experimental): Participants will receive anticoagulation therapy with warfarin, aiming for a reduced INR range of 1.5-2.0, which is lower than the current standard recommendation. Warfarin dosing will be regularly adjusted based on INR monitoring throughout the 6-month study period. | Drug | Low-intensity INR group |
| Warfarin (standard anticoagulation)Standard INR group (Active Comparator): Participants will receive anticoagulation therapy with warfarin, maintaining an INR within the standard therapeutic range of 2.0-3.0. Warfarin dosing adjustments will be made regularly according to standard clinical practice and INR monitoring throughout the 6-month study period. | Drug | Standard INR group |
Primary outcome
Incidence of composite hemocompatibility-related events
Time frame: Within 6 months after randomization
The primary outcome is defined as a composite of hemocompatibility-related events including major bleeding (INTERMACS major bleeding criteria), stroke (ischemic or hemorrhagic), and pump thrombosis occurring within 6 months post-randomization. Events will be centrally adjudicated based on standardized INTERMACS definitions.
18 secondary outcomes
All-cause mortality
Time frame: Within 6 months after randomization
Cardiac death
Time frame: Within 6 months after randomization
LVAD pump thrombosis
Time frame: Within 6 months after randomization
LVAD-related thromboembolism
Time frame: Within 6 months after randomization
Transient ischemic attack (TIA)
Time frame: Within 6 months after randomization
Stroke
Time frame: Within 6 months after randomization
Systemic embolism
Time frame: Within 6 months after randomization
Myocardial infarction
Time frame: Within 6 months after randomization
Major bleeding event
Time frame: Within 6 months after randomization
Composite (cardiac death, pump thrombosis, thromboembolism)
Time frame: Within 6 months after randomization
Composite (cardiac death, thrombosis, stroke, embolism, MI)
Time frame: Within 6 months after randomization
Composite (stroke, embolism, TIA, MI)
Time frame: Within 6 months after randomization
Composite (death, stroke, embolism, TIA, MI)
Time frame: Within 6 months after randomization
LVAD-related readmission
Time frame: Within 6 months after randomization
LVAD-related reoperation
Time frame: Within 6 months after randomization
Time in therapeutic range (TTR)
Time frame: Within 6 months after randomization
Out-of-range INR proportion
Time frame: Within 6 months after randomization
Warfarin dose adjustments
Time frame: Within 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 29655662Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11.
- Results publication: PubMed 28146651Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.
- Results publication: PubMed 37659882Desai SR, Hwang NC. 2023 ISHLT Guidelines for Mechanical Circulatory Support. J Cardiothorac Vasc Anesth. 2023 Dec;37(12):2419-2422. doi: 10.1053/j.jvca.2023.07.044. Epub 2023 Aug 8. No abstract available.
- Results publication: PubMed 27959709Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
- Results publication: PubMed 29526139Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin (low-intensity anticoagulation) and Warfarin (standard anticoagulation) in people with Advanced Heart Failure and Left Ventricular Assist Devices, run by Asan Medical Center at 1 site in South Korea.
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 26 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Min-Seok Kim, MD, PhD (+82-2-3010-5416, msk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite hemocompatibility-related events (time frame: Within 6 months after randomization). 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 NCT07081035, which also lists 5 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 23 Jul 2025.