Actively Recruiting

Age: 18Years +
All Genders
ID04117230

Clinical Outcomes in Patients Needing Peripheral ECMO or Impella Circulatory Support Devices

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-06

1500

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting detailed clinical and procedural data from patients who receive extracorporeal membrane oxygenation (ECMO) or Impella device implantation to support heart function. This observational study includes all eligible patients undergoing these treatments at participating sites to assess their clinical outcomes over time. The use of these devices is based on the treating physician's decision and is independent of the study. The study includes all patients receiving either a peripheral cannulated veno-arterial ECMO or microaxial flow pump devices like Impella (2.5, 5, CP, or RP) or newer left ventricular or left atrial ascending aorta devices. Data is collected prospectively from patients who have provided informed consent or, if unable, consent is obtained from relatives or waived by an ethics committee. The study follows patients to evaluate their outcomes after device implantation. Participants will be monitored to record clinical events and complications, including death rates at 1 month and 6 months after cardiogenic shock, adverse cardiac and cerebrovascular events, vascular complications, bleeding issues, and need for vascular surgery. The time of device implantation and duration of mechanical circulatory support are also tracked. Functional assessments such as the New York Heart Association classification and modified Rankin scale are included. This data collection continues until August 2034, aiming to improve understanding of outcomes after these circulatory support therapies.

CONDITIONS

Brief Title

CARDSUP - SWISS Circulatory Support Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 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 ethics committee
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Device support duration up to 6 months

Participants undergo implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (Impella) device as decided by their treating physician.

Visits occur during device support as part of routine care

Long-term Monitoring

Duration - Up to 6 months after device implantation

Participants are followed to assess clinical outcomes including survival, cardiac events, and complications after device implantation.

Follow-up visits over 6 months

Trial Site Locations

Total: 5 locations

1

Universitätsspital Basel

Basel, Switzerland, 4053

Actively Recruiting

2

Insel Gruppe AG, Inselspital Bern

Bern, Switzerland, 3010

Actively Recruiting

3

Luzerner Kantonsspital

Lucerne, Switzerland, 3600

Actively Recruiting

4

Kantonsspital Winterthur

Winterthur, Switzerland, 8400

Actively Recruiting

5

Stadtspital Treimli

Zurich, Switzerland, 8063

Actively Recruiting

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Research Team

L

Lukas C Hunziker Munsch, Prof MD

M

Monika Fürholz, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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