Trial Outcomes & Findings for Synchronized Cardiac Assist for Cardiogenic Shock (NCT NCT02697006)

NCT ID: NCT02697006

Last Updated: 2022-09-16

Results Overview

Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.

• Recruitment status: COMPLETED
• Target enrollment: 47 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-09-16

Participant Flow

Participant milestones

Measure	High-Risk PCI Group Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)
Overall Study STARTED	34	13
Overall Study COMPLETED	31	9
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High-Risk PCI Group n=34 Participants Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock n=13 Participants Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)	Total n=47 Participants Total of all reporting groups
Age, Continuous	71.3 years STANDARD_DEVIATION 10.9 • n=34 Participants	67.5 years STANDARD_DEVIATION 11.7 • n=13 Participants	70.3 years STANDARD_DEVIATION 11.2 • n=47 Participants
Sex: Female, Male Female	3 Participants n=34 Participants	4 Participants n=13 Participants	7 Participants n=47 Participants
Sex: Female, Male Male	31 Participants n=34 Participants	9 Participants n=13 Participants	40 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	34 participants n=34 Participants	13 participants n=13 Participants	47 participants n=47 Participants

PRIMARY outcome

Timeframe: 30 days

Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.

Outcome measures

Measure	High-Risk PCI Group n=34 Participants Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock n=13 Participants Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)
Number of Participants With Device and Procedure Related Serious Adverse Events	11 Participants	5 Participants

PRIMARY outcome

Timeframe: 24 hours

Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).

Outcome measures

Measure	High-Risk PCI Group n=34 Participants Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock n=13 Participants Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)
Number of Participants Treated With Technical Success of the Device	34 Participants	13 Participants

PRIMARY outcome

Timeframe: 7 days

Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.

Outcome measures

Measure	High-Risk PCI Group n=34 Participants Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock n=13 Participants Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)
Number of Participants With Device Performance Success	34 Participants	13 Participants

Adverse Events

High-Risk PCI Group

Serious events: 10 serious events

Other events: 0 other events

Deaths: 3 deaths

Cardiogenic Shock

Serious events: 5 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	High-Risk PCI Group n=34 participants at risk Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab	Cardiogenic Shock n=13 participants at risk Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)
Blood and lymphatic system disorders Bleeding event	23.5% 8/34 • Number of events 8 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Infections and infestations Wound infection groin	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Musculoskeletal and connective tissue disorders Compartment syndrome	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Nervous system disorders Deterioration in bispectral index	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Cardiac disorders Death	8.8% 3/34 • Number of events 3 • up to study exit at 30 days post-procedure, an average of 1 month	38.5% 5/13 • Number of events 5 • up to study exit at 30 days post-procedure, an average of 1 month
Cardiac disorders Coronary artery perforation	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Metabolism and nutrition disorders Syncope/Dehydration	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Blood and lymphatic system disorders Thrombophlebitis	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Infections and infestations Urinary Tract Infection	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Gastrointestinal disorders Colonic impaction	2.9% 1/34 • Number of events 1 • up to study exit at 30 days post-procedure, an average of 1 month	0.00% 0/13 • up to study exit at 30 days post-procedure, an average of 1 month
Vascular disorders Lower leg ischemia due to arterial clot	0.00% 0/34 • up to study exit at 30 days post-procedure, an average of 1 month	23.1% 3/13 • Number of events 3 • up to study exit at 30 days post-procedure, an average of 1 month

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anja Derlet-Savoia

Fresenius MCD

Phone: +49 6172 608 2801

Email: Anja.Derlet@fmc-ag.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place