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

Heart Failure Cardiomyopathy

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

Inclusion Criteria3

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 Criteria20

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