Clinical trials: Temporary Mechanical Circulatory Support
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.
Cardiogenic Shock
Unloading in Heart Failure Cardiogenic Shock
The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by…
- Trial name
- UNLOAD HF-CS (NCT05064202)
- Testing
- Impella 5.5, Inotropes
- Where
- 5 sites in Netherlands
- Volunteers
- 456 people
- Sponsor
- Amsterdam UMC, location VUmc
Coronary Artery Disease
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
- Trial name
- Vortex-FIH (NCT04674111)
- Testing
- Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 5 people
- Sponsor
- Boston Scientific Corporation
Cardiogenic Shock, Heart Failure
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock.
- Conditions
- Cardiogenic Shock, Heart Failure, Inflammation
- Trial name
- CORTISHOCK-P (NCT07461961)
- Testing
- Methylprednisone, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brigham and Women's Hospital
Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes.
- Conditions
- Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease, Cardiogenic Shock
- Trial name
- POTOK (NCT07149714)
- Testing
- iVAC 2L
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
ECMO, Cardiogenic Shock
The ECMOCYP (cytochromes P450 Activity) Study
Prospective open label observational study including patients requiring a tMCS (VA-ECMO or Impella® CP) or in in cardiogenic shock according to the SCAI (Society for Cardiovascular Angiography and Interventions) ESC (European…
- Conditions
- ECMO, Cardiogenic Shock, Temporary Mechanical Circulatory Support
- Trial name
- NCT06662084
- Testing
- phenotype
- Where
- Switzerland
- Volunteers
- 46 people
- Sponsor
- University Hospital, Geneva