Actively Recruiting
Impella RP Flex Registry
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...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of device support as per routine care
Participants receive implantation of the right-sided ventricular assist device for right heart support.
Duration - Up to 1 year post implant
Participants are monitored for outcomes up to 1 year after device implantation.
Regular follow-up visits during the monitoring period
Trial Site Locations
Total: 31 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Pima Heart and Vascular
Tucson, Arizona, United States, 85718
Actively Recruiting
3
Baptist Health Heart Failure and Transplant Institute
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
University of Southern California (Keck USC)
Los Angeles, California, United States, 90033
Actively Recruiting
6
Advent Health Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
7
Tampa General
Tampa, Florida, United States, 33606
Actively Recruiting
8
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
11
Ascension St. John Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
12
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
13
Providence St. Patrick Hospital
Missoula, Montana, United States, 59802
Actively Recruiting
14
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
15
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
16
Northwell Health/Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
17
Montefiore Medical Center - Moses
The Bronx, New York, United States, 10467
Actively Recruiting
18
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Actively Recruiting
19
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
20
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
21
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
22
Legacy Research Institute (Legacy Emanuel Medical Center)
Portland, Oregon, United States, 97232
Actively Recruiting
23
Oregon Health and Science System
Portland, Oregon, United States, 97239
Actively Recruiting
24
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
25
Medical City Heart Hospital Dallas
Dallas, Texas, United States, 75243
Actively Recruiting
26
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
27
Memorial Herman Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
28
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
29
MultiCare Institute for Research Innovation
Puyallup, Washington, United States, 98372
Actively Recruiting
30
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Actively Recruiting
31
Froedtert Hospital (Medical College of Wisconsin)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Stacie Hallaway, Sr. Clinical Project Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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