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Recruiting NCT06637644

Impella RP Flex with Smart Assist

Observational Right Ventricular (RV) Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Right-sided ventricular assist device.
Who it may be relevant to
Registry conditions: Right Ventricular (RV) Dysfunction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impella RP Flex Registry

Overview

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

Interventions

  • Device Right-sided ventricular assist device
    Percutaneous device for right heart support

Primary outcome measures

  • Objectives [Time frame: 1 year post implant]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 31 centers
  • University of Alabama at Birmingham — Birmingham
  • Pima Heart and Vascular — Tucson
  • Baptist Health Heart Failure and Transplant Institute — Little Rock
  • Arkansas Heart Hospital — Little Rock
  • University of Southern California (Keck USC) — Los Angeles
  • Advent Health Orlando — Orlando
  • Tampa General — Tampa
  • Ochsner Clinic Foundation — New Orleans
  • … and 23 more centers

Identifiers

NCT: NCT06637644 · Impella RP Flex Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗