I21.9
Conditions
Interventions
Group 1: Single Arm study: Collection of data from routine clinical care of patients with myocardial infarction and cardiogenic shock to evaluate access-site-related complications following Impella CP
Sponsors
Abiomed Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Acute myocardial infarction (AMI) of < 36 hours duration from symptom onset to cath lab arrival, confirmed by: a. ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI) or b. ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels 3. Cardiogenic shock that develops under one of the following conditions: a. Prior to primary PCI, with < 24 hours from the onset of shock to cath lab arrival, or b. Within 12 hours after initiating primary PCI. c. Cardiogenic shock is confirmed by at least two of the following: i. Peripheral signs of tissue hypoperfusion (arterial blood lactate = 2.5 mmol/l or SvO2 < 55 % with a normal PaO2) ii. Systolic blood pressure < 100 mmHg or need for vasoactive agents to maintain systolic blood pressure = 100 mmHg Hemodynamic criteria represented by a cardiac index of < 2.2 L/min/m2 or a cardiac power output = 0.6 W 4. Patient received PCI to treat the AMI-CS 5. Patient was supported with Impella CP as the initial MCS device for cardiogenic shock 6. Duration of Impella use = 8 hours and = 5 days 7. Planned use of PerQseal Elite device as the first large-bore closure device in Intensive Care Unit (ICU) 8. Subject or legally designated representative (LDR) has provided written informed consent for participation in the observational study
Exclusion criteria
Exclusion criteria: 1. Surgical cannulation (arterial access obtained via surgical cut-down) 2. Patients with evidence of arterial diameter stenosis > 20 % or anterior or circumferential calcification within 20 mm proximal or distal to target arteriotomy site 3. Unilateral or bilateral lower extremity amputation 4. Patients who are hemodynamically compromised and require escalation to other MCS devices following Impella CP removal 5. Infection of the procedural access-site or suspected systemic active infection, including any fever 6. Pregnant or lactating women 7. Platelet count < 75k, history of bleeding diathesis, known bleeding coagulopathy, or unwillingness to receive blood transfusions 8. Patients receiving oral anticoagulation therapy with Vitamin K antagonists (e.g., warfarin) or non-vitamin K oral anticoagulants (NOACs/DOACs) such as apixaban, rivaroxaban, edoxaban, or dabigatran 9. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint 10. Known allergy to any of the materials used in the PerQseal Elite or PerQseal Elite Introducer (refer to PerQseal IFU for materials list).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoints will be evaluated at hospital discharge or at 30 days post enrollment, whichever occurs first. • The safety endpoints will be rate of Impella CP access-site-related major bleeding, major vascular complications and major non-vascular complications: o Rate of access-site-related major bleeding complications related to PerQseal Elite device, defined as BARC = 3 o Rate of access-site-related major vascular complications related to PerQseal Elite device o Rate of access-site-related major non-vascular complications related to the PerQseal Elite device | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints will be evaluated at hospital discharge or at 30 days post enrollment, whichever occurs first. • Treatment success rate - defined as the number of subjects who meet PerQseal Elite technical success without experiencing device related access-site complication • Technical success rate - defined as the number of PerQseal Elite devices deployed and achieve hemostasis without need for more than 10 minutes of manual compression proximal to access-site or alternative treatment at target access-site, divided by the total number of PerQseal Elite devices in which deployment was attempted. • Operator evaluation of device easy-of-use (Physician survey) • Length of ICU stay post-enrollment • Length of hospital stay post-enrollment • Time to ambulate post-enrollment | — |
Countries
Germany
Contacts
Public ContactUwe Anzenberger
Abiomed Europe GmbH
Outcome results
None listed