Trial Outcomes & Findings for Impella CP With VA ECMO for Cardiogenic Shock (NCT NCT03431467)

Last Updated: 2025-11-19

Results Overview

The number of subjects treated with this standardized ECMO protocol with either (i) no additional therapy or (ii) Impella CP for LV mechanical unloading who experience myocardial recovery defined as: survival free from mechanical circulatory support, heart transplantation or inotropic support.

Recruitment status

TERMINATED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

At forty five days.

Results posted on

2025-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Control VA-ECMO alone per standard clinical protocol.	Experimental VA-ECMO with early institution of Impella CP LV venting Impella-CP LV Vent: Patients randomised to the experimental arm will have an Impella-CP implanted in addition to VA-ECMO within a maximum of 10 hours of institution of VA-ECMO
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=9 Participants VA-ECMO alone per standard clinical protocol.	Experimental n=8 Participants VA-ECMO with early institution of Impella CP LV venting Impella-CP LV Vent: Patients randomised to the experimental arm will have an Impella-CP implanted in addition to VA-ECMO within a maximum of 10 hours of institution of VA-ECMO	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=9 Participants	6 Participants n=8 Participants	13 Participants n=17 Participants
Age, Categorical >=65 years	2 Participants n=9 Participants	2 Participants n=8 Participants	4 Participants n=17 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	2 Participants n=8 Participants	4 Participants n=17 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	6 Participants n=8 Participants	13 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	8 participants n=8 Participants	17 participants n=17 Participants

PRIMARY outcome

Timeframe: At forty five days.

Population: Survival free from mechanical circulatory support, heart transplantation or inotropic support at 40 days.

Outcome measures

Outcome measures
Measure	Control 40 day Survival n=9 Participants VA-ECMO alone per standard clinical protocol survival at 40 days.	Experimental 40 Day Survival n=8 Participants VA-ECMO with early institution of Impella CP LV venting survival at 40 days. Impella-CP LV Vent: Patients randomised to the experimental arm will have an Impella-CP implanted in addition to VA-ECMO within a maximum of 10 hours of institution of VA-ECMO
Recovery From Cardiogenic Shock. Survival at Discharge	5 Participants	4 Participants
Recovery From Cardiogenic Shock. In Hospital Mortality	4 Participants	4 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 4 deaths

Experimental

Serious events: 0 serious events

Other events: 2 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=8 participants at risk VA-ECMO alone per standard clinical protocol.	Experimental n=8 participants at risk VA-ECMO with early institution of Impella CP LV venting Impella-CP LV Vent: Patients randomised to the experimental arm will have an Impella-CP implanted in addition to VA-ECMO within a maximum of 10 hours of institution of VA-ECMO
Vascular disorders Loss of pulse	25.0% 2/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Vascular disorders Thromboembolism	37.5% 3/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	25.0% 2/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Infections and infestations Localized non-device infection	25.0% 2/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Infections and infestations Percutaneous cannula site infection	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Cardiac disorders Cardiac arrythmias	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	25.0% 2/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Nervous system disorders Neurological dysfunction	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	25.0% 2/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Vascular disorders Major bleeding	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Surgical and medical procedures Washout	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Surgical and medical procedures Tracheostomy	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Renal and urinary disorders Renal dysfunction	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.
Respiratory, thoracic and mediastinal disorders Dysphagia	0.00% 0/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.	12.5% 1/8 • Adverse events were collected from time of enrollment through removal of ECMO and at hospital discharge, 30 days (+/-15 days) and 180 days (+/- 60 days) after initial ECMO institution. Serious Adverse Events (SAEs) and any unexpected SAEs will be collected from the time of ECMO insertion through removal and hospital discharge. All SAEs will be reported using modified INTERMACS adverse event (AE) categories. The INTERMACS AE definitions have been modified to exclude pediatrics and include SAEs related to extracorporeal mechanical assist devices, including percutaneous cannula insertion.

Additional Information

Dr. Christian Bermudez

The Hospital of the University of Pennsylvania

Phone: 2153165151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place