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

A

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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