Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
Active, not recruiting
- Conditions
- Cardiogenic ShockPCI PatientsMechanical 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
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 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 Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT) 12 months 30-day overall and cardiovascular mortality 30 day
Trial Locations
- Locations (1)
AOU Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
AOU Città della Salute e della Scienza di Torino🇮🇹Torino, Italy