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โ† Trials
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Impella Reverse Remodeling in End-Stage Heart Failure

Recruitingn/aAges 18 Years - anyAllColumbia University
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In plain words

What the trial is, and whether it could suit you

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 funct

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Columbia University
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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