Evaluating heart recovery with Impella 5.5 in severe heart failure patients
A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support
This study is testing how well the Impella 5.5 heart device helps people with severe heart failure recover after a heart attack.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06800716 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with dilated cardiomyopathy and severe heart failure requiring temporary mechanical support.
Not a fit: Patients with certain types of cardiomyopathy, prior heart transplants, or those currently using other mechanical support devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients with end-stage heart failure.
How similar studies have performed: While there has been significant research on LVADs, the specific use of Impella 5.5 for reverse remodeling in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.