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ACTIVE NOT RECRUITING NA

IMpella-Protected cArdiaC Surgery Trial (IMPACT)

NCT05529654 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.

Interventions

  • DEVICE Impella 5.5 with SmartAssist

Study Locations (20)

New York

  • NYU Langone Health — New York
  • New York- Presbyterian Hospital/ Columbia University Medical Center — New York
  • Montefiore Medical Center — The Bronx

California

  • Keck School of Medicine — Los Angeles
  • Tri-City Medical Center — San Diego

Massachusetts

  • Mass General Hospital — Boston
  • Brigham & Women's — Boston

Texas

  • University of Texas Austin Dell Medical School/Ascension Texas — Austin
  • Baylor Scott and White - Plano — Plano

Arkansas

  • Cardiology Associates Research Group — Jonesboro

Florida

  • NCH Rooney Heart Institute — Naples

Georgia

  • Emory University Hospital — Atlanta

Minnesota

  • Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital — Minneapolis

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-09-21
Est. Completion 2025-10
Phase NA

Sponsor

Abiomed

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05529654

The ClinicalTrials.gov registry entry for NCT05529654 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Left Ventricular Dysfunction appearing as the primary indexed condition, and to 1 intervention — of which Impella 5.5 with SmartAssist is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05529654 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05529654 about?

NCT05529654 is a clinical study titled "IMpella-Protected cArdiaC Surgery Trial (IMPACT)". The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical...

What is the current status of trial NCT05529654?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-09-21. Estimated completion is 2025-10.

What conditions does trial NCT05529654 study?

This clinical trial studies the following conditions: Left Ventricular Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05529654?

The interventions under investigation include: Impella 5.5 with SmartAssist (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05529654?

This trial is sponsored by Abiomed, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05529654 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial