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Mechanical Circulatory Support

Mechanical Circulatory Support for Heart Failure (TEAM-HF Trial)

N/A

Recruiting

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

3. Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons.

4. NYHA Class IIIB or NYHA Class IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of the HeartMate 3 LVAS compared to standard medical therapy in patients with advanced heart failure who are able to move around and don't need intravenous medication

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the HeartMate 3 LVAS include bleeding, infection, stroke, device malfunction, and other complications related to surgery or having a mechanical device support your heart.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk less than 300 meters in 6 minutes due to heart failure.

Select...

My heart condition severely limits my daily activities.

Select...

I either have a CardioMEMS PA Sensor implanted or am willing to get one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes

Secondary study objectives

All-cause hospitalizations

Days alive and outside of the hospital

Freedom from major adverse events (MAE) in the HM3 group

+4 more

Other study objectives

Finkelstein-Schoenfeld Win Ratio

Survival free of urgent LVAD or transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Single Arm RegistryExperimental Treatment2 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 GroupExperimental Treatment3 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 GroupExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CardioMEMS HF System

2016

N/A

~1460

0 / 3Eligibility criteria met