Impella RP Flex with Smart Assist
Impella RP Flex Registry
1 other identifier
observational
200
1 country
31
Brief Summary
To capture observational data of the Abiomed Impella RP Flex in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2024
CompletedFirst Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedOctober 15, 2024
September 1, 2024
1.8 years
September 18, 2024
October 9, 2024
Conditions
Outcome Measures
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.
1 year post implant
Study Arms (1)
Patients implanted with right-sided ventricular assist device
Interventions
Percutaneous device for right heart support
Eligibility Criteria
This study includes sites from the US
You may qualify if:
- Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (31)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Pima Heart and Vascular
Tucson, Arizona, 85718, United States
Baptist Health Heart Failure and Transplant Institute
Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
University of Southern California (Keck USC)
Los Angeles, California, 90033, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Tampa General
Tampa, Florida, 33606, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension St. John Hospital
Detroit, Michigan, 48236, United States
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, 55433, United States
Providence St. Patrick Hospital
Missoula, Montana, 59802, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Northwell Health/Lenox Hill Hospital
New York, New York, 10075, United States
Montefiore Medical Center - Moses
The Bronx, New York, 10467, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101, United States
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, 45219, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Research Institute (Legacy Emanuel Medical Center)
Portland, Oregon, 97232, United States
Oregon Health and Science System
Portland, Oregon, 97239, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Medical City Heart Hospital Dallas
Dallas, Texas, 75243, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Memorial Herman Texas Medical Center
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
MultiCare Institute for Research Innovation
Puyallup, Washington, 98372, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Froedtert Hospital (Medical College of Wisconsin)
Milwaukee, Wisconsin, 53226, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2024
First Posted
October 15, 2024
Study Start
May 29, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
October 15, 2024
Record last verified: 2024-09