Mechanical Circulatory Support for Heart Failure

(TEAM-HF Trial)

Recruiting at 57 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the HeartMate 3 LVAS, a mechanical circulatory support device, for individuals with serious heart failure. It compares the device to standard heart failure treatments to determine which is more effective for those not on constant IV medication. Participants may receive the HeartMate 3 device or continue with their current heart treatments. The trial suits individuals who have experienced heart failure hospitalizations in the past year, face difficulties with daily activities due to heart issues, and are open to having a small device implanted to monitor their heart. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance heart failure treatments.

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 prior data suggests that the HeartMate 3 LVAS is safe for heart failure patients?

Research shows that the HeartMate 3 LVAS, a device that helps the heart pump blood, is generally safe for people with severe heart failure. Studies have found that this device improves survival rates, similar to heart transplants, over two years. Most patients handle it well. However, some risks exist. About 8.3% of patients experience issues with the right side of the heart not pumping well while in the hospital. Other less common issues include stroke and abdominal bleeding. Overall, the device is considered safe and effective for long-term management of heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HeartMate 3 LVAS because it offers a novel approach to managing advanced heart failure. Unlike traditional treatments that rely heavily on medication to manage symptoms, the HeartMate 3 is a mechanical circulatory support device that takes over some of the heart's workload. This device uses a magnetic levitation system to ensure smoother blood flow, potentially reducing complications such as blood clotting. Additionally, its design aims to enhance durability and reliability, offering a promising alternative for patients who need long-term support beyond what medications can provide.

What evidence suggests that the HeartMate 3 LVAS is effective for heart failure?

Research has shown that the HeartMate 3 LVAS (Left Ventricular Assist System) effectively treats advanced heart failure. One study found that patients using the HeartMate 3 had better survival rates and improved heart function compared to those using an earlier version, the HeartMate II. Two-year follow-up data confirmed these benefits, indicating its effectiveness for long-term use. Another analysis found that survival rates with the HeartMate 3 were similar to those of heart transplant patients, which is impressive. The device aids the heart in pumping blood, reducing symptoms and improving quality of life. Overall, strong evidence supports the HeartMate 3's safety and effectiveness for individuals with severe heart failure. Participants in this trial may be randomized to receive the HeartMate 3 device or continue with medical therapy per established heart failure guidelines, depending on their mean pulmonary artery pressure (PAP). ^{1 4 6 7 8}

Who Is on the Research Team?

Kelly O'Connell, PhD

Principal Investigator

Abbott

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

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 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 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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39214797/

HeartMate 3: Analysis of Outcomes and Future Directions

This review provides a comprehensive synthesis of the safety and efficacy of the 2-year and 5-year HeartMate LVAD outcomes, highlighting key findings.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1053077024005317

HeartMate 3: Analysis of Outcomes and Future Directions

This review provides a comprehensive synthesis of the safety and efficacy of the 2-year and 5-year HeartMate LVAD outcomes, highlighting key findings.

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160054S008B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The data in this application support the reasonable assurance of safety and effectiveness of the HeartMate 3 LVAS in providing long-term mechanical circulatory ...

4.

cardiovascular.abbott

cardiovascular.abbott/us/en/hcp/products/heart-failure/left-ventricular-assist-devices/heartmate-3/clinical-evidence/journal-articles.html

HeartMate 3 LVAD Journal Articles

The data from two-year follow-up of the MOMENTUM 3 full cohort demonstrates: Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS ...

5.

nyp.org

nyp.org/advances/article/cardiology/new-analysis-shows-lvad-therapy-offers-similar-survival-outcomes-as-heart-transplantation-for-younger-heart-failure-patients

New Analysis Shows LVAD Therapy Offers Similar Survival ...

A recent comparative analysis of data from the MOMENTUM 3 trial and UNOS registry found two-year survival rates were the same among younger heart failure ...

6.

smw.ch

smw.ch/index.php/smw/article/download/3529/5964/22336

Clinical outcomes of HeartMate 3 left ventricular assist ...

The main results of this study are: (1) Patients with ad- vanced heart failure supported with a HeartMate 3 LVAD device had a favourable 2 ...

7.

cardiovascular.abbott

cardiovascular.abbott/us/en/hcp/products/heart-failure/left-ventricular-assist-devices/heartmate-3.html

HeartMate 3 LVAD Overview | Abbott

With significantly improved outcomes and survival comparable to heart transplant at 2 years, our LVAD device technology is making a better future possible for ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11508271/

Nine Years of Continuous Flow LVAD (HeartMate 3)

The main cause for in-hospital mortality was right ventricular failure (8.3%), followed by stroke, abdominal bleeding, and multi-organ failure ( ...