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NCT Number: NCT07034599

Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.

All patients undergoing an implantation of a durable left ventricular assist device and monitored by pulmonary artery catheter showing no adverse events after surgery are included in the study and ventilated for 15 minutes using extra thoracic negative pressure ventilation and usual intrathoracic positive pressure ventilation. Hemodynamics changes between both ventilation modes, especially focussing on right ventricular function and measured by a pulmonary artery catheter, are compared.

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Key information

Conditions

Critical Illness Cardiovascular Diseases Disease Attributes Heart Diseases Heart Failure LVAD Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients after implantation of a durable left ventricular assist device

Exclusion criteria

  • Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation

Treatment and study plan

Negative Pressure Ventilation

Device

All participants are ventilated with negative pressure ventilation first

positive pressure ventilation

Device

All participants are ventilated using positive pressure ventilation after negative pressure ventilation

Primary outcomes

  1. RVSWI

    Time frame: one minute

    right ventricular stroke work index

Study contacts

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

Matthias Heringlake, Prof. Dr. med.

CONTACT

[email protected]

038355 70-2500

Sponsors and collaborators

Lead sponsor

Karlsburg Hospital

Other

Collaborators

  • University Hospital Freiburg

Registry information

Acronym: NPV LVAD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Feb 18, 2026

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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