+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

All Genders
ID06637644

Observational Registry for Patients Using the Abiomed Impella RP Flex Right Ventricular Assist Device

Led by Abiomed Inc. · Updated on 2024-10-15

200

Participants Needed

31

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study aims to collect real-world data on the Abiomed Impella RP Flex, a device designed to support the right side of the heart. The study focuses on patients with right ventricular dysfunction who have received this mechanical circulatory support. The purpose is to understand how the device performs outside of controlled clinical trial settings. Participants will have received the right-sided ventricular assist device called the Impella RP Flex, which is a percutaneous device used to support right heart function. There are no separate treatment groups or placebo comparisons since this is an observational registry of patients already implanted with the device. During the study, researchers will monitor patient outcomes up to one year after the device implant. They will collect data related to the objectives set for this time frame, focusing on safety and performance as observed in routine clinical use. Participants ongoing health and device function will be tracked through standard medical follow-up and data collection methods.

CONDITIONS

Brief Title

Impella RP Flex with Smart Assist

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects who received mechanical circulatory support with an Impella RP Flex will be considered eligible for the registry.
Not Eligible

You will not qualify if you...

Research Team

S

Stacie Hallaway, Sr. Clinical Project Manager

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here