Actively Recruiting
Impella Reverse Remodeling in End-Stage Heart Failure
Led by Columbia University · Updated on 2025-07-31
50
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Abiomed Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Impella Reverse Remodeling in End-Stage Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Dilated cardiomyopathy with left ventricular end-diastolic diameter greater than 5.5 cm and ejection fraction less than 25%
- Need for temporary mechanical circulatory support with Impella 5.5 as a bridge to transplant or transplant decision as determined by treating physician
You will not qualify if you...
- Use of intra-aortic balloon pump for more than 7 days before Impella 5.5 implantation
- Support with other mechanical circulatory devices like ECMO or ventricular assist devices before Impella 5.5
- Presence of congenital heart disease
- Restrictive or hypertrophic cardiomyopathy including hypertrophic obstructive cardiomyopathy, amyloidosis, or sarcoidosis
- Evidence of acute myocarditis by biopsy
- Previous heart transplantation
- Mechanical aortic or mitral valve
- Known aortic diseases such as Marfan syndrome or Morbus Erdheim-Gsell
- Left ventricular thrombus or rupture
- Cardiac tamponade
- Presence of atrial or ventricular septal defects
- Severe right ventricular failure needing mechanical support
- Severe peripheral vascular disease preventing Impella placement
- Recent stroke causing significant neurological deficit
- Hypercoagulable disease preventing device implantation
- Severe thrombocytopenia (platelets less than 50,000)
- Contraindication to anticoagulation
- Suspected or known pregnancy or lactation
- Being part of a vulnerable population
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University
New York, New York, United States, 10032
Actively Recruiting
Research Team
A
Adil Yunis, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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