- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05820451
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
January 29, 2024 updated by: Abiomed Inc.
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
330
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stacie Hallaway
- Phone Number: 978-646-1560
- Email: shallaway@abiomed.com
Study Contact Backup
- Name: Oksana Bradley
- Phone Number: 978-882-8479
- Email: obradley@abiomed.com
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama
-
Contact:
- Felice Cook
- Email: fycook@uabmc.edu
-
-
Arizona
-
Tucson, Arizona, United States, 85712
- Recruiting
- Pima Heart and Vascular (Tuscon Medical Center)
-
Contact:
- Aleksander Herber
- Email: aleksander.herber@pimaheartandvascular.com
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Recruiting
- Arkansas Heart Hospital
-
Contact:
- Leybi Ramirez-Kelly
- Email: leybi.ramirez-kelly@arheart.com
-
-
California
-
Los Angeles, California, United States, 90033
- Recruiting
- Keck USC Medical Center
-
Contact:
- Blanca Garcia
- Email: blanca.garcia2@med.usc.edu
-
-
Florida
-
Orlando, Florida, United States, 32804
- Recruiting
- Advent Helath Orlando
-
Contact:
- Zoe Bancilhon
- Email: zoe.bancilhon@adventhealth.com
-
Tampa, Florida, United States, 33606
- Not yet recruiting
- Tampa General Hospital
-
Contact:
- Courtney Nicholas
- Email: courtneynicholas@tgh.org
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford
-
Contact:
- Tia Seale
- Email: tseale1@hfhs.org
-
Detroit, Michigan, United States, 48236
- Recruiting
- Ascension St. John Hospital
-
Contact:
- Katie Burke
- Email: katie.burke@ascension.org
-
-
Montana
-
Missoula, Montana, United States, 59802
- Recruiting
- Providence St. Patrick
-
Contact:
- Kelli Hoffman
- Email: Kelli.Hoffman@providence.org
-
-
Nebraska
-
Omaha, Nebraska, United States, 68105
- Recruiting
- University of Nebraska
-
Contact:
- Barbara Hoover-Schultz
- Email: b.hooverschultz@unmc.edu
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Robert Wood Johnson University Hospital
-
Contact:
- Nivedita Rajiv
- Email: nr505@rwjms.rutgers.edu
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Recruiting
- Christ Hospital
-
Contact:
- Ellen Anderson
- Email: Ellen.Anderson@thechristhospital.com
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- John Dornblaser
- Email: dornblas@ohsu.edu
-
Portland, Oregon, United States, 97205
- Recruiting
- Montefiore Medical Center - Moses
-
Contact:
- Jane Wilson
- Email: jwilson4@montefiore.org
-
Portland, Oregon, United States, 97227
- Recruiting
- Legacy Emanuel
-
Contact:
- Karla Kummer
- Email: KKUMMER@LHS.ORG
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- UPMC Presbyterian
-
Contact:
- Abbey Sung
- Email: sunga3@upmc.edu
-
-
Texas
-
Dallas, Texas, United States, 75226
- Recruiting
- Baylor Scott and White (Baylor Heart and Vascular)
-
Contact:
- Alexis Evans
- Email: alexis.evans@bswhealth.org
-
Plano, Texas, United States, 75093
- Recruiting
- The Heart Hospital Baylor Plano
-
Contact:
- Manaf Alom
- Email: manaf.alom@BSWHealth.org
-
-
Washington
-
Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart
-
Contact:
- Lauren Wilcox
- Email: lauren.wilcox@providence.org
-
Tacoma, Washington, United States, 98405
- Recruiting
- MultiCare Tacoma General
-
Contact:
- Shirley Warner
- Email: shirley.warner@multicare.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All subjects who received an Impella in which a bicarbonate-based purge solution was used
Description
Left Sided Impella
Inclusion Criteria:
- Left-sided Impella with bicarbonate in the purge
Exclusion Criteria:
- Known LV thrombus
Right Sided Impella
Inclusion Criteria:
- Right-sided Impella with bicarbonate in the purge
Exclusion Criteria:
- Known pulmonary thromboemboli
- Known DVT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Left sided device
All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5.
|
US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.
|
Right sided device
All patients implanted with a right sided support Impella device -this includes the Impella RP
|
US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint Left Sided Impella
Time Frame: From hospital admission until hospital discharge, average 5 days
|
Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
|
From hospital admission until hospital discharge, average 5 days
|
Primary Endpoint Right Sided Impella
Time Frame: From hospital admission until hospital discharge, average 5 days
|
Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)
|
From hospital admission until hospital discharge, average 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amin Medjamia, MD, Abiomed Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
April 7, 2023
First Posted (Actual)
April 19, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABMD-CIP-21-02-SS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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