Clinical Trials Logo
  1. Home
  2. Cardiogenic Shock
  3. NCT05820451
  4. Details
NCT05820451 Clinical Trial

Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Cardiogenic Shock Clinical Trial

Official title:
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05820451
Other study ID # ABMD-CIP-21-02-SS01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date March 1, 2024

Study information
Verified date January 2024
Source Abiomed Inc.
Contact Stacie Hallaway
Phone 978-646-1560
Email shallaway@abiomed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.

Recruitment information / eligibility
Status Recruiting
Enrollment 330
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution
US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.
• Impella RP with Sodium Bicarbonate used as purge solution
US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.

Locations
Country Name City State
United States University of Alabama Birmingham Alabama
United States Christ Hospital Cincinnati Ohio
United States Baylor Scott and White (Baylor Heart and Vascular) Dallas Texas
United States Ascension St. John Hospital Detroit Michigan
United States Henry Ford Detroit Michigan
United States Arkansas Heart Hospital Little Rock Arkansas
United States Keck USC Medical Center Los Angeles California
United States Providence St. Patrick Missoula Montana
United States Robert Wood Johnson University Hospital New Brunswick New Jersey
United States University of Nebraska Omaha Nebraska
United States Advent Helath Orlando Orlando Florida
United States UPMC Presbyterian Pittsburgh Pennsylvania
United States The Heart Hospital Baylor Plano Plano Texas
United States Legacy Emanuel Portland Oregon
United States Montefiore Medical Center - Moses Portland Oregon
United States Oregon Health & Science University Portland Oregon
United States Providence Sacred Heart Spokane Washington
United States MultiCare Tacoma General Tacoma Washington
United States Tampa General Hospital Tampa Florida
United States Pima Heart and Vascular (Tuscon Medical Center) Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Endpoint Left Sided Impella Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus From hospital admission until hospital discharge, average 5 days
Primary Primary Endpoint Right Sided Impella Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) From hospital admission until hospital discharge, average 5 days
See also
  Status Clinical Trial Phase
Recruiting NCT03283995 - Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology
Active, not recruiting NCT04325035 - The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock Phase 2
Active, not recruiting NCT05100836 - SURPASS Impella 5.5 Study
Not yet recruiting NCT05106491 - Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients N/A
Completed NCT02301819 - ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock N/A
Completed NCT01367743 - Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock Phase 4
Recruiting NCT05728359 - Genomic Determinants of Outcome in Cardiogenic Shock
Recruiting NCT05699005 - Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO Phase 1
Not yet recruiting NCT06338345 - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients N/A
Completed NCT03436641 - Microcirculation in Cardiogenic Shock
Recruiting NCT03313687 - SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK
Recruiting NCT05506449 - The RECOVER IV Trial N/A
Completed NCT04144660 - "Treatment Use of ECMO In Pregnancy or Peripartum Patient."
Completed NCT04548739 - Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Recruiting NCT04141410 - Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis
Not yet recruiting NCT05879276 - Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. Phase 3
Enrolling by invitation NCT05570864 - Score TO Predict SHOCK - STOP SHOCK
Completed NCT02591771 - Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock Phase 2
Terminated NCT02279979 - Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial N/A
Completed NCT01374867 - CardShock Study and Registry N/A