CARDSUP - SWISS Circulatory Support Registry

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04117230

Collaborator

(none)

1,500

Enrollment

Locations

180.7

Anticipated Duration (Months)

300

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock

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).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)

Actual Study Start Date :

Aug 9, 2019

Anticipated Primary Completion Date :

Aug 31, 2034

Anticipated Study Completion Date :

Aug 31, 2034

Outcome Measures

Primary Outcome Measures

Number of deceased participants at 1 month after cardiogenic shock [30 days]
All-cause mortality at 30 days

Secondary Outcome Measures

Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants [6 months]
Major adverse cardiac and cerebrovascular events (MACCE)
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
Statistical and medical analysis of bleeding complications (minor, major) reported by participants [6 months]
Bleeding complications (minor, major)
Implantation time of MCS-device [6 months]
Implantation time of MCS-device
Support time under MCS [6 months]
Support time under MCS
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.
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.
Number of deceased participants at 6 month after cardiogenic shock [6 months]
Mortality at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitätsspital Basel	Basel	Switzerland	4053
2	Insel Gruppe AG, Inselspital Bern	Bern	Switzerland	3010
3	Luzerner Kantonsspital	Luzern	Switzerland	3600
4	Kantonsspital Winterthur	Winterthur	Switzerland	8400
5	Stadtspital Treimli	Zürich	Switzerland	8063

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Study Chair: Lukas C Hunziker Munsch, PD, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT04117230

Other Study ID Numbers:

4075

First Posted:

Oct 7, 2019

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Cardiogenic

Study Results

No Results Posted as of Feb 24, 2022