NCT06800716Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 4 Dec 2024
- Primary completion date
- Nov 2028
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT06800716
What you commit to
- Study type: Observational
- Planned participants: 50
- From 4 Dec 2024 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
- Prior heart transplantation
Other illness
- Congenital heart disease
- Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
- Cardiac tamponade
- 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
Other
- Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
- Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
- Evidence of acute myocarditis by endomyocardial biopsy
- Mechanical aortic / mitral valve
- Left Ventricular thrombus
- Left Ventricular rupture
- Presence of an Atrial or Ventricular Septal Defect
- Severe thrombocytopenia (\<50,000)
- Contraindication to anticoagulation
- Suspected or known pregnancy or lactating women
- Subject belongs to a vulnerable population
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.