Impella Reverse Remodeling in End-Stage Heart Failure

Launched by COLUMBIA UNIVERSITY · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Impella Reverse Remodeling in End-Stage Heart Failure," is designed to learn more about how patients recover from heart attacks when they are supported by a special device called the Impella 5.5 left ventricular assist device (LVAD). This study will involve about 50 participants at Columbia University Irving Medical Center and will take around 14 months, which includes a short screening period, a treatment phase lasting 40 days, and a year of follow-up. Participants will share their health records and undergo several tests, such as walking assessments and strength tests, to help researchers understand how the device impacts heart recovery.

To be eligible for this study, participants should be at least 18 years old and have a specific type of heart disease called dilated cardiomyopathy, which affects how well the heart pumps blood. However, certain medical conditions and previous treatments may disqualify someone from participating. This trial aims to gather important data to improve heart failure treatments and help doctors make better decisions for their patients in the future.

Gender

ALL

Eligibility 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