Impella 5.5 SmartAssist / Reduced Ejection Fraction Heart Failure / Heart Failure · Interventional Study

INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

ClinicalTrials.gov · September 10, 2026

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

This is a planned interventional study of Impella 5.5 combined with guideline-directed medical therapy in heart failure cardiogenic shock, with a primary composite outcome of death, heart failure hospitalization, or heart replacement at 180 days. No results have been reported; the study has not yet begun recruitment.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure; age from 18 Years; to 80 Years. Intervention: Single arm study. n = 250. 15 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a study registration with no reported results; enrollment has not yet begun. Evidence cannot be assessed until outcomes are published.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation) (assessed at Timeframe: 180-days post-enrollment)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationHeart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure; age from 18 Years; to 80 Years

Sample size250

InterventionSingle arm study

Setting15 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment250

Primary outcome measureComposite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)

Primary outcome timeframe180-days post-enrollment

Caveats

This is a registry record only; no results are reported or available for assessment.
Study recruitment has not yet begun (status: NOT_YET_RECRUITING).
No control or comparator arm is described in the registry record.
Study phase is listed as NA; no blinding, randomization, or methodological details are disclosed.

Evidence assessment

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.

Study design

insufficient

Interventional study; phase not specified; no control or comparator arm stated.

Directness

insufficient

Primary outcome is composite clinical measure; no results reported yet to assess directness.

Consistency

insufficient

Single planned study; no comparative data or replication available.

Risk of bias

insufficient

Study not yet recruiting; blinding, randomization, and conduct details not disclosed.

Sample adequacy

insufficient

Planned enrollment 250 participants; actual sample size and power analysis not reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06965504). This is a study registration, not published results. Lead sponsor: Abiomed Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure. Interventions: DEVICE: Impella 5.5 SmartAssist. Primary outcome measures: Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation) , Timeframe: 180-days post-enrollment. Brief summary: The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AbiomedImpella 5.5 SmartAssistReduced Ejection Fraction Heart FailureNCT06965504Heart FailureCardiogenic Shock