RecruitingNCT06800716

Impella Reverse Remodeling in End-Stage Heart Failure

A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support


Sponsor

Columbia University

Enrollment

50 participants

Start Date

Dec 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center. Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study. Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a temporary heart pump (called an Impella 5.5) can help the heart recover and potentially avoid a transplant in patients with severe heart failure caused by a weakened, enlarged heart. **You may be eligible if...** - You are 18 or older - You have dilated cardiomyopathy (an enlarged, weakened heart with ejection fraction below 25%) - Your doctor has recommended an Impella heart pump as a bridge while awaiting a transplant decision **You may NOT be eligible if...** - You have been on a different mechanical heart pump (balloon pump) for more than 7 days before the Impella implant - You have already been on another type of mechanical heart support device (such as ECMO or a ventricular assist device) before the Impella Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Columbia University

New York, New York, United States

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NCT06800716


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