Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study (DTU)

Abiomed

Status: Completed

Conditions: STEMI

Treatments: Device: Impella unloading prior to PPCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000270

DTU - Safety and Feasibility

Details and patient eligibility

About

Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Full description

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.

Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Enrollment: 50 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Age 21-80 years
• First myocardial infarction
• Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads
• Signed Informed Consent

Main Exclusion Criteria:

• Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
• Inferior STEMI or suspected right ventricular failure
• Suspected or known pregnancy
• Suspected active infection
• History or known hepatic insufficiency prior to catheterization
• On dialysis therapy
• Known contraindication to:
• Undergoing MRI or use of gadolinium
• Heparin, pork, pork products or contrast media
• Receiving a drug-eluting stent
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Prolonged unloading prior to PPCI

Active Comparator group

Description:

Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention

Treatment:

Device: Impella unloading prior to PPCI

Immediate unloading prior to PPCI

Active Comparator group

Description:

Activation of Impella CP immediately prior to primary percutaneous coronary intervention

Treatment:

Device: Impella unloading prior to PPCI