Impella RP Flex with Smart Assist

Recruiting

• Conditions: Right Ventricular (RV) Dysfunction

• Registration Number: NCT06637644
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objectives	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.

Trial Locations

Locations (31)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

Baptist Health Heart Failure and Transplant Institute; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Southern California (Keck USC); 🇺🇸 Los Angeles, California, United States

Advent Health Orlando; 🇺🇸 Orlando, Florida, United States

Tampa General; 🇺🇸 Tampa, Florida, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

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