NCT06800716 · Columbia University
Impella Reverse Remodeling in End-Stage Heart Failure
What this study 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 the usual treatment. There are three stages in this study: screening, treatment and post treatment.
View original scientific description
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.
Primary outcome measures
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and approximately Day 40
A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
Time frame: Baseline and approximately Day 40
A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.
Change in Cardiac Index
Time frame: Baseline and approximately Day 40
A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).
Change in Pulmonary Capillary Wedge Pressure
Time frame: Baseline and approximately Day 40
A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Collaborators
Abiomed Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations