Impella RP Flex with Smart Assist

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAbiomed Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

This study includes sites from the US

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Right-sided ventricular assist device

    Device

    Percutaneous device for right heart support

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients implanted with right-sided ventricular assist device1 intervention

Trial outcomes

Primary outcomes

1

Objectives

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.

Time frame
1 year post implant

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.