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NCT05529654 · ClinicalTrials.gov registry record · NA

IMpella-Protected cArdiaC Surgery Trial (IMPACT)

A NA study of Left Ventricular Dysfunction, sponsored by Abiomed.

Active
Registry status
NA
Development phase
100
Enrollment target
20
Study locations

NCT05529654: Active NA study of Left Ventricular Dysfunction, sponsored by Abiomed.

NCT05529654 is a NA study of Left Ventricular Dysfunction that is active but no longer recruiting, run by Abiomed. The registered enrollment target is 100 participants, below the 1,224-participant average among 7 other Left Ventricular Dysfunction trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05529654, a NA study of Left Ventricular Dysfunction, is active but no longer recruiting, sponsored by Abiomed.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
20
Study locations

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
Abiomed

20 total trials

What the registry record for NCT05529654 still lists

NCT05529654 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,224-participant average among 7 other Left Ventricular Dysfunction trials with a reported enrollment target (92% lower).

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.

NCT05529654 names 20 study sites across 15 states, led by New York, California, Massachusetts.

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.

What interventions are being tested in trial NCT05529654?

The interventions under investigation include: Impella 5.5 with SmartAssist (DEVICE).

Who is sponsoring clinical trial NCT05529654?

This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.

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.

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Source: ClinicalTrials.gov NCT05529654, the US trial registry maintained by the National Library of Medicine. NCT05529654 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.