Clinical trial NCT06637644: Impella RP Flex with Smart Assist
Official title: Impella RP Flex Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Ventricular (RV) Dysfunction
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes sites from the US

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Objectives
timeFrame: 1 year post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Heart Failure and Transplant Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California (Keck USC)
state: California
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart and Vascular Institute
state: Minnesota
city: Missoula
country: United States
facility: Providence St. Patrick Hospital
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses
state: New York
city: New York
country: United States
facility: Northwell Health/Lenox Hill Hospital
state: New York
city: Wilmington
country: United States
facility: Novant Health New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at the Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Legacy Research Institute (Legacy Emanuel Medical Center)
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science System
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Dallas
country: United States
facility: Medical City Heart Hospital Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Herman Texas Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Puyallup
country: United States
facility: MultiCare Institute for Research Innovation
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital (Medical College of Wisconsin)
state: Wisconsin
Study officials:
References: