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NCT Number: NCT04117230

CARDSUP - SWISS Circulatory Support Registry

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.

Recruiting

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of deceased participants at 1 month after cardiogenic shock

    Time frame: 30 days

    All-cause mortality at 30 days

Secondary outcomes

  1. Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants

    Time frame: 6 months

    Major adverse cardiac and cerebrovascular events (MACCE)

  2. Statistical and medical analysis of vascular complications (VARC) reported by participants

    Time frame: 6 months

    Vascular complications (VARC)

  3. Statistical and medical analysis of vascular surgery needed by participants

    Time frame: 6 months

    Need for vascular surgery

  4. Statistical and medical analysis of bleeding complications (minor, major) reported by participants

    Time frame: 6 months

    Bleeding complications (minor, major)

  5. Implantation time of MCS-device

    Time frame: 6 months

    Implantation time of MCS-device

  6. Support time under MCS

    Time frame: 6 months

    Support time under MCS

  7. Analysis of New York Heart Association (NYHA) Classification for participants

    Time frame: 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.

  8. Modified rankin scale

    Time frame: 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.

  9. Number of deceased participants at 6 month after cardiogenic shock

    Time frame: 6 months

    Mortality at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lukas C Hunziker Munsch, Prof MD

CONTACT

[email protected]

0041316322111

Monika Fürholz, MD

CONTACT

[email protected]

00413163221 11

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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)

Acronym: CARDSUP

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Oct 7, 2019
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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