Impella RP Flex with Smart Assist

October 9, 2024 updated by: Abiomed Inc.

Impella RP Flex Registry

To capture observational data of the Abiomed Impella RP Flex in a real-world setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stacie Hallaway, Sr. Clinical Project Manager
  • Phone Number: 839-216-3087
  • Email: shallawa@its.jnj.com

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Pima Heart and Vascular
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Baptist Health Heart Failure and Transplant Institute
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California (Keck USC)
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent Health Orlando
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Metropolitan Heart and Vascular Institute
    • Montana
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Providence St. Patrick Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health/Lenox Hill Hospital
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Novant Health New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27101
        • Recruiting
        • Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Research Center at The Christ Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97232
        • Recruiting
        • Legacy Research Institute (Legacy Emanuel Medical Center)
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Medical City Heart Hospital Dallas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Herman Texas Medical Center
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
    • Washington
      • Puyallup, Washington, United States, 98372
        • Recruiting
        • MultiCare Institute for Research Innovation
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital (Medical College of Wisconsin)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes sites from the US

Description

Inclusion Criteria:

  • Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients implanted with right-sided ventricular assist device
Device: Right-sided ventricular assist device
Percutaneous device for right heart support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objectives
Time Frame: 1 year post implant
Survival at hospital discharge, with follow-ups at 30 days, 90 days, and 1-year post-discharge of Impella RP patients from real-world surveillance data.
1 year post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Impella RP Flex Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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