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

Active, not recruiting

• Conditions: Cardiogenic Shock; PCI Patients; Mechanical Circulatory Support

• Registration Number: NCT06690567
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2024-10-10
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
long-term overall mortality	12 months

Secondary Outcome Measures

Name	Time	Method
Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT)	12 months
30-day overall and cardiovascular mortality	30 day
Rate of bleedings according to the BARC classification	12 months
Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition)	12 months
Rate of neurological events (stroke and TIA)	12 months

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy