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

November 13, 2024 updated by: Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy
        • AOU Citta della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Paitents with cardiogenic shock or CHIP-PCI who underwent Impella device implantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantation
Impella implantation as only intervention needed
Device: Impella implantation
To implante Impella

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
long-term overall mortality
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMMERGE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiogenic Shock

Clinical Trials on Impella implantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe