Mechanical Circulatory Support for Heart Failure

(TEAM-HF Trial)

Recruiting at 26 trial locations

Overseen By Nourdine Chakouri, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must be taking: Betablockers, ACE inhibitors, Diuretics, SGLT2 inhibitors

Disqualifiers: Inotrope use, Thyroid disease, Valvular heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

850 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on guideline-directed medical therapy with certain heart medications for at least 30 of the last 90 days.

What data supports the effectiveness of the treatment HeartMate 3 LVAS for heart failure?

The HeartMate 3 device is shown to be effective for long-term support in patients with advanced heart failure, providing improved survival outcomes and serving as a bridge to heart transplantation or as a permanent solution. It features a magnetically levitated rotor that enhances blood flow and reduces complications, making it a reliable option for those with severe heart conditions. ^{1 2 3 4 5}

Is the HeartMate 3 LVAD safe for humans?

The HeartMate 3 LVAD has been studied for safety, showing improved outcomes like reduced need for reoperations and fewer disabling strokes compared to older devices. However, some risks like cerebrovascular events (strokes or bleeding in the brain) still exist, although survival and device longevity have improved. ^{1 3 6 7 8}

How is the HeartMate 3 LVAS treatment different from other heart failure treatments?

The HeartMate 3 LVAS is unique because it uses a fully magnetically levitated rotor to pump blood, which reduces damage to blood cells and improves blood flow. This design helps avoid complications like strokes and the need for additional surgeries, making it a safer long-term option for patients with severe heart failure. ^{1 5 7 9 10}

What is the purpose of this trial?

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Research Team

Kelly O'Connell, PhD

Principal Investigator

Abbott

Eligibility Criteria

This trial is for adults with advanced heart failure who are not IV inotrope-dependent. They must have a left ventricular ejection fraction (LVEF) under 30%, limited ability to walk, and recent hospital visits due to heart failure. Participants either already have or agree to get a CardioMEMS sensor implanted and may receive the HeartMate 3 device if selected.

Inclusion Criteria

My average pulmonary artery pressure is 30 mmHg or higher.

I have signed the consent form for this study.

I have been hospitalized or visited the ER for heart failure in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Arm Treatment

Participants with elevated mean PAP are randomized to receive the HeartMate 3 LVAS or continue guideline-directed medical therapy

2 years

Regular follow-up visits as per trial protocol

Single Arm Registry

Participants who do not meet the mean PAP threshold continue medical therapy and are monitored for heart failure progression

2 years

Regular follow-up visits as per trial protocol

Follow-up

Participants are monitored for survival, quality of life, and other outcomes after treatment

5 years

Treatment Details

Interventions

• HeartMate 3 LVAS

Trial Overview The TEAM-HF IDE trial is testing whether the HeartMate 3 Left Ventricular Assist System (LVAS) offers more benefits compared to standard medical therapy for patients with severe heart failure. It's checking safety and how well it works by comparing two groups: one receiving the device and one getting regular treatment.

Participant Groups

Group I: Single Arm Registry Experimental Treatment 2 Interventions

Patients who do not meet the mean PAP threshold (mean PAP \<30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.

Group II: Randomized Arm - HM3 Group Experimental Treatment 3 Interventions

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.

Group III: Randomized Arm - Control Group Experimental Treatment 2 Interventions

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

In a study of 50 patients with advanced heart failure, the HeartMate 3 left ventricular assist system (LVAS) demonstrated a high 6-month survival rate of 92%, exceeding the performance goal of 88%, and significantly reduced mortality risk by 66% compared to predicted survival rates.

The LVAS was found to be safe with a favorable adverse event profile, showing no pump malfunctions or thrombosis, and led to improvements in quality of life and functional status, as measured by various health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. Netuka, I., Sood, P., Pya, Y., et al.[2022]

The HeartMate 3 left ventricular assist device is effective for treating patients with left ventricular heart failure and can be used for myocardial recovery, as a bridge to transplant, or as destination therapy.

The innovative technique described combines device implantation with left ventricular reconstruction using a double patch, which reduces thrombotic risk and helps restore proper heart shape, making it a safe option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricle reconstruction and heartmate3 implantation. The "double patch technique". Piperata, A., Kalscheuer, G., Pernot, M., et al.[2022]

In a study of 170 patients supported with the HeartMate 3 (HM3) ventricular assist device, the overall mortality rate was low at less than 8%, indicating excellent outcomes for patients, particularly in a pediatric population with a median support time of 102.5 days.

Smaller patients (BSA <1.4 m²) experienced higher rates of adverse events such as infections, renal dysfunction, and ischemic strokes, suggesting a need for targeted improvements in care for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding use of the HeartMate 3 ventricular assist device in pediatric and adult patients within the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). O'Connor, MJ., Shezad, M., Ahmed, H., et al.[2023]

The HeartMate XVE left ventricular assist system (LVAS) showed a significant reduction in serious mechanical failures, particularly percutaneous lead breaks, compared to the older HeartMate VE system, indicating improved reliability.

At 6 months, 97% of XVE devices were free of serious mechanical failures, compared to 92% for VE, suggesting that recent design enhancements may enhance device durability as LVADs become more common for long-term therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HeartMate VE LVAS design enhancements and its impact on device reliability. Dowling, RD., Park, SJ., Pagani, FD., et al.[2019]

In a study involving 16 male patients with advanced heart failure, the Heartmate III left ventricular assist device demonstrated a high overall survival rate of 92.9% at 6 months post-implantation, indicating its efficacy as a treatment option for this high-risk population.

Despite some complications, including bleeding and infections, the Heartmate III was successfully implanted in patients with low INTERMACS profiles, suggesting it is a viable option for patients with severe heart failure who are awaiting transplant or require long-term support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Years of Experience in the Implantation of Heartmate III. Mendes, V., Cerca, C., Crosset, M., et al.[2019]

In a study of 27 patients receiving the HeartMate 3 (HM3) left ventricular assist device, the 1-year survival rate was 85.2%, with no cases of pump thrombosis or strokes reported, indicating a strong safety profile.

The main complication observed was LVAD-related infection in 22.2% of patients, but overall, the HM3 demonstrated excellent midterm outcomes with no technical complications or need for pump exchanges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. Hanke, JS., Dogan, G., Zoch, A., et al.[2019]

In a study of 289 patients, the HeartMate 3 (HM3) Left Ventricular Assist System showed a 69% rate of survival free from hemocompatibility-related adverse events (HRAEs) at 6 months, compared to 55% for the HeartMate II (HMII), indicating better safety and efficacy for the HM3.

The HM3 system also had significantly fewer cases of pump thrombosis and nondisabling strokes compared to the HMII, suggesting that its design enhances hemocompatibility and reduces complications associated with blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure. Uriel, N., Colombo, PC., Cleveland, JC., et al.[2018]

In a study of 6205 patients with centrifugal-flow left ventricular assist devices, the Abbott HeartMate3 (HM3) showed a significantly lower incidence of major neurologic adverse events (NAEs) compared to the Medtronic HeartWare HVAD, with rates of 6.4% versus 16.4%, respectively.

The increased risk of NAEs with the HVAD persisted beyond the early post-implantation period, indicating that patients with this device had a 5.71 times higher hazard of experiencing major NAEs during the constant hazard phase compared to those with the HM3.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score-Matched Analysis From the Intermacs Registry. Cho, SM., Mehaffey, JH., Meyers, SL., et al.[2021]

The HeartMate 3 ventricular assist device (VAD) was successfully implanted in 35 patients, including those as small as 19 kg, demonstrating its potential for use in older children and small adults with complex congenital heart disease.

The study reported a high survival rate of 97% during a median follow-up of 78 days, with no strokes or pump thrombosis, indicating the HeartMate 3's safety and efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with the HeartMate 3 continuous-flow ventricular assist device in pediatric patients and patients with congenital heart disease: A multicenter registry analysis. O'Connor, MJ., Lorts, A., Davies, RR., et al.[2021]

The HeartMate 3 LVAD has shown improved hemocompatibility, leading to a reduced rate of disabling strokes and pump thrombosis in patients with end-stage heart failure, based on analysis from nine articles including clinical trials and studies.

Despite its advancements, there remains a significant risk of surgical and gastrointestinal bleeding, highlighting the need for ongoing evaluation of anticoagulation management and surgical techniques to mitigate these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in HeartMate 3: What we know so far. Lanfear, AT., Hamandi, M., Fan, J., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Left ventricle reconstruction and heartmate3 implantation. The "double patch technique". [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Expanding use of the HeartMate 3 ventricular assist device in pediatric and adult patients within the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

HeartMate VE LVAS design enhancements and its impact on device reliability. [2019]

5. Portugal pubmed.ncbi.nlm.nih.gov

Two Years of Experience in the Implantation of Heartmate III. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score-Matched Analysis From the Intermacs Registry. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Early experience with the HeartMate 3 continuous-flow ventricular assist device in pediatric patients and patients with congenital heart disease: A multicenter registry analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Trends in HeartMate 3: What we know so far. [2020]