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CARDSUP - SWISS Circulatory Support Registry

NCT ID: NCT04117230

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-09

Study Completion Date

2034-08-31

Brief Summary

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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

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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.

Conditions

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Cardiogenic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukas C Hunziker Munsch, Prof MD

Role: STUDY_CHAIR

University of Bern

Locations

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Universitätsspital Basel

Basel, , Switzerland

Site Status RECRUITING

Insel Gruppe AG, Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status RECRUITING

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status RECRUITING

Stadtspital Treimli

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Lukas C Hunziker Munsch, Prof MD

Role: CONTACT

Phone: 0041316322111

Email: [email protected]

Monika Fürholz, MD

Role: CONTACT

Phone: 00413163221 11

Email: [email protected]

Facility Contacts

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Gregor Leibundgut, Prof MD

Role: primary

Monika Fürholz, MD

Role: primary

Florim Cuculi, PD MD

Role: primary

Stefan Blöchlinger, PD MD PhD

Role: primary

Gregor Fahrni, PD MD

Role: primary

Other Identifiers

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4075

Identifier Type: -

Identifier Source: org_study_id