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NCT00596726 · ClinicalTrials.gov registry record · Phase 2

RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study

A Phase 2 study of Cardiac Surgery, sponsored by Abiomed.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target
7
Study locations

NCT00596726 is a Phase 2 study of Cardiac Surgery that has completed, run by Abiomed. The registered enrollment target is 17 participants, below the 745-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT00596726, a Phase 2 study of Cardiac Surgery, has completed, sponsored by Abiomed.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target
7
Study locations

Study Summary

To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.

Conditions Studied

Interventions

  • DEVICE IMPELLA LP/LD 5.0

Study Locations (7)

Massachusetts

  • Massach General Hospital - Boston
  • Brigham & Womens - Boston

Maryland

  • University of Maryland - Baltimore

New Jersey

  • Robert Wood Johnson - New Brunswick

New York

  • Columbia Presbyterian Hospital - New York

Pennsylvania

  • Hershey Medical Center - Hershey

Texas

  • Texas Heart - Houston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2006-08
Est. Completion 2010-05
Phase Phase 2

Sponsor

Abiomed

20 total trials

What the Registry Record Tells You About NCT00596726

The ClinicalTrials.gov registry entry for NCT00596726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 745-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (98% lower). The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiac Surgery appearing as the primary indexed condition, and to 1 intervention - of which IMPELLA LP/LD 5.0 is the first listed.

NCT00596726 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Massachusetts, Maryland, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00596726 about?

NCT00596726 is a clinical study titled "RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study". To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.

What is the current status of trial NCT00596726?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2006-08. Estimated completion is 2010-05.

What conditions does trial NCT00596726 study?

This clinical trial studies the following conditions: Cardiac Surgery.

What interventions are being tested in trial NCT00596726?

The interventions under investigation include: IMPELLA LP/LD 5.0 (DEVICE).

Who is sponsoring clinical trial NCT00596726?

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

Where is trial NCT00596726 being conducted?

This trial has 7 study locations across Maryland, Massachusetts, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.