Impella Reverse Remodeling in End-Stage Heart Failure
Recruiting · NCT06800716 · Observational (researchers observe without assigning treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Columbia University - New York, New York, United States