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Cardiomyopathy / Heart Failure · Observational Study
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a study registration describing a planned observational study of cardiac remodeling in end-stage heart failure patients receiving Impella 5.5 LVAD support at a single center. No results are posted in this registry record, and the study is currently recruiting; clinical impact cannot be assessed until outcome data are available.
Observational. Heart Failure, Cardiomyopathy; age from 18 Years; accepts healthy volunteers. Intervention: Decompensated patients on the waitlist for heart transplant…. n = 50. 1 site: United States.
This is a study registration describing a planned observational study of cardiac remodeling in end-stage heart failure patients receiving Impella 5.5 LVAD support at a single center. No results are posted in this registry record, and the study is currently recruiting; clinical impact cannot be assessed until outcome data are available.
This is a registry record only; no results, efficacy data, or safety outcomes are reported.
The source did not state who this applies to in practice.
This is an ongoing observational registry study with no results reported; it describes a planned investigation of Impella support effects on cardiac remodeling in end-stage heart failure, insufficient to assess efficacy or safety at this stage.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06800716). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Heart Failure, Cardiomyopathy. Primary outcome measures: Change in Left Ventricular Ejection Fraction (LVEF) , Baseline and approximately Day 40; Change in Left Ventricular End-Diastolic Diameter (LVEDD) , Baseline and approximately Day 40; Change in Cardiac Index , Baseline and approximately Day 40; Change in Pulmonary Capillary Wedge Pressure , Baseline and approximately Day 40. Brief 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.
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