Clinical trial NCT06690567: Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
Official title: Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiogenic Shock
PCI Patients
Mechanical Circulatory Support
Keywords: IMPELLA
CARDIOGENIC SHOCK
COMPLEX PCI
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paitents with cardiogenic shock or CHIP-PCI who underwent Impella device implantation

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.


Eligibility criteria: 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

Primary outcomes:
measure: long-term overall mortality
timeFrame: 12 months
Secondary outcomes:
measure: 30-day overall and cardiovascular mortality
timeFrame: 30 day
measure: Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT)
timeFrame: 12 months
measure: Rate of bleedings according to the BARC classification
timeFrame: 12 months
measure: Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition)
timeFrame: 12 months
measure: Rate of neurological events (stroke and TIA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
References:
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