Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Subjects who received mechanical circulatory support with an Impella RP Flex will be considered eligible for the registry.
You will not qualify if you...
Research Team
S
Stacie Hallaway, Sr. Clinical Project Manager
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