CARDSUP - SWISS Circulatory Support Registry

Recruiting

• Conditions: Cardiogenic Shock

• Registration Number: NCT04117230
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Detailed Description

This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative).

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Study Timeline

• Study Start: 2019-08-09
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2034-08-31
• Study Completion: 2034-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Age > 18 years
• Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
• Signed informed consent by patient or relative or waived consent by EC

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of deceased participants at 1 month after cardiogenic shock	30 days	All-cause mortality at 30 days

Secondary Outcome Measures

Name	Time	Method
Statistical and medical analysis of vascular complications (VARC) reported by participants	6 months	Vascular complications (VARC)
Statistical and medical analysis of vascular surgery needed by participants	6 months	Need for vascular surgery
Analysis of New York Heart Association (NYHA) Classification for participants	6 months	The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain. Class I is defined as no symptoms and no limitation in ordinary physical activity worsening to Class IV defined as severe limitations.
Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants	6 months	Major adverse cardiac and cerebrovascular events (MACCE)
Implantation time of MCS-device	6 months	Implantation time of MCS-device
Support time under MCS	6 months	Support time under MCS
Modified rankin scale	6 months	Modified rankin scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological Disability. The scale ranges form 0-6 with 0 defined as no Symptoms and 5 being severe Symptoms and 6 defined as death.
Statistical and medical analysis of bleeding complications (minor, major) reported by participants	6 months	Bleeding complications (minor, major)
Number of deceased participants at 6 month after cardiogenic shock	6 months	Mortality at 6 months

Trial Locations

Locations (5)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Insel Gruppe AG, Inselspital Bern; 🇨🇭 Bern, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Stadtspital Treimli; 🇨🇭 Zürich, Switzerland