CARDSUP - SWISS Circulatory Support Registry | NCT04117230

Studies
CARDSUP - SWISS Circulatory Support Registry

NCT04117230

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Recruiting

Last Update Posted

Dec 6, 2024Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Cardiogenic Shock

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2019Actual

Primary Completion Date

Aug 31, 2034Estimated

Completion Date

Aug 31, 2034Estimated

First Submitted Date

Oct 3, 2019

First Submission Date that Met QC Criteria

Oct 3, 2019

First Posted Date

Oct 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of deceased participants at 1 month after cardiogenic shock	All-cause mortality at 30 days	30 days

Secondary Outcomes

Measure	Description	Time Frame
Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants	Major adverse cardiac and cerebrovascular events (MACCE)	6 months
Statistical and medical analysis of vascular complications (VARC) reported by participants

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In an all-comers design, every patient receiving an MCS will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lukas C Hunziker Munsch, Prof MD	Contact	0041316322111		lukas.hunziker@insel.ch
Monika Fürholz, MD	Contact	00413163221 11		monika.fuerholz@insel.ch

Overall Officials

Name	Affiliation	Role
Lukas C Hunziker Munsch, Prof MD	University of Bern	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsspital Basel	Recruiting	Basel		4053	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided