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Clinical Trials in Germany / NCT04782232
Recruiting Observational

Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart

NCT04782232 · tracked via the Priya Life Science Germany tracker
Sponsor
Berlin Heart GmbH
Phase
Observational
Started
2021-06-01
Last updated
2025-02-17

Condition(s) studied

Heart FailureUniventricular HeartVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention due to observational design

Study summary

The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form, * The indications on RVAD and BVAD use of the EXCOR VAD apply, * Patient shall be on transplant list or at least eligible for HTx, * BSA (body surface area) greater than or equal to 1.2 m². Exclusion Criteria: * Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent, * The contraindications of EXCOR VAD apply.

Primary outcome measure(s)

  • Rate of mortality — 30 days
    Short-term mortality
  • Rate of major bleeding — 30 days
    Short-term rate of major bleeding
  • Rate of thrombosis — 30 days
    Short-term rate of thrombosis
  • Survival to heart transplantation — up to 12 months
    Long-term survival to heart transplantation

Trial sites (1)

FacilityCityRegionStatus
LMU Klinikum Munich Germany Recruiting

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Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device. Recruiting
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP) Recruiting
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04782232 on ClinicalTrials.gov ↗ ← All trials in Germany