Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention (IMMERGE)

A.O.U. Città della Salute e della Scienza

Status: Active, not recruiting

Conditions: PCI Patients; Cardiogenic Shock; Mechanical Circulatory Support

Treatments: Device: Impella implantation

Study type: Observational

Funder types: Other

Identifiers

NCT06690567

IMMMERGE

Details and patient eligibility

About

The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females ≥ 18 years-old with CS or CHIPs
• Impella® device implanted (CP, 5, 5.5)

Exclusion criteria

• Age < 18 years
• No Impella implanted

Trial design

700 participants in 1 patient group

Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantation

Description:

Impella implantation as only intervention needed

Treatment:

Device: Impella implantation