Evaluating heart recovery with Impella 5.5 in severe heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand heart attack recovery in patients using the Impella 5.5 left ventricular assist device (LVAD) as part of their standard care. It involves three stages: screening, treatment, and post-treatment, with a total of approximately 50 participants enrolled at Columbia University Irving Medical Center. The study will collect clinical data, perform functional and neurocognitive testing, and analyze blood and heart tissue samples to assess the effects of the device on heart function and recovery over a period of 14 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Dilated cardiomyopathy (LVEDD \> 5.5 cm and LVEF \<25%)
* Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion

Exclusion Criteria:

* Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
* Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
* Congenital heart disease
* Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
* Evidence of acute myocarditis by endomyocardial biopsy
* Prior heart transplantation
* Mechanical aortic / mitral valve
* Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
* Left Ventricular thrombus
* Left Ventricular rupture
* Cardiac tamponade
* Presence of an Atrial or Ventricular Septal Defect
* Severe right ventricular (RV) Failure requiring mechanical RV support
* Severe peripheral vascular disease precluding placement of the Impella System
* Recent stroke resulting in significant neurological deficit
* Hypercoagulable disease precluding device implantation
* Severe thrombocytopenia (\<50,000)
* Contraindication to anticoagulation
* Suspected or known pregnancy or lactating women
* Subject belongs to a vulnerable population

Where it's running

• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Adil Yunis, MS — Columbia University
• Study coordinator: Adil Yunis, MD
• Email: aay2122@cumc.columbia.edu
• Phone: 212-305-0211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.