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Recruiting

NCT Number: NCT06637644

Impella RP Flex with Smart Assist

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

Recruiting

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Key information

Conditions

Right Ventricular (RV) Dysfunction

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Right-sided ventricular assist device

Device

Percutaneous device for right heart support

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stacie Hallaway, Sr. Clinical Project Manager

CONTACT

[email protected]

839-216-3087

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Impella RP Flex Registry

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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