Impella 5.5 for Heart Failure
(INTeGRATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The study will evaluate if Impella 5.5® support in heart failure reduced ejection fraction (HFrEF) patients presenting with decompensated heart failure (HF) and cardiogenic shock will facilitate the initiation and optimization of guideline directed medical therapy (GDMT) during the hospital stay and post-discharge.
Who Is on the Research Team?
Adam DeVore, MD, MHS
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for heart failure patients with reduced ejection fraction who are in cardiogenic shock. They should have a history of heart failure for less than 5 years, low blood pressure or need drugs to maintain it, and not be fully treated with guideline-directed medications. Participants must consent to the study and can't be severely dehydrated.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Impella 5.5 support and initiation of guideline directed medical therapy (GDMT) during hospital stay
Post-discharge Follow-up
Participants are monitored for GDMT optimization and heart recovery up to 90 days post-discharge
Long-term Follow-up
Participants are monitored for outcomes such as GDMT optimization, heart recovery, and adverse events up to one year post-discharge
What Are the Treatments Tested in This Trial?
Interventions
- Impella 5.5 SmartAssist
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abiomed Inc.
Lead Sponsor
Johnson & Johnson
Industry Sponsor