Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Negative-pressure versus positive-pressure breathing after LVAD implantation

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

Run by Karlsburg Hospital · NCT07034599 · Data updated 2026-11-12

The team will try a 15-minute period of extra-thoracic negative pressure ventilation versus standard positive-pressure ventilation in people right after durable LVAD implantation to see which better supports right ventricular function and hemodynamics.

More Heart Failure trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorKarlsburg Hospital
Academic / other
Locations1 site (Karlsburg)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedOctober 1, 2026
Study endsDecember 1, 2026
Registry record updatedFebruary 18, 2026
Trial IDNCT07034599 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults who are hemodynamically stable after durable LVAD implantation, monitored with a pulmonary artery catheter, and able to tolerate the extra-thoracic cuirass device.

Probably not a fit

Patients who experienced surgical complications, remain hemodynamically or ventilator-unstable, cannot fit the cuirass, or are not LVAD recipients are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Stable patients who have just received a durable left ventricular assist device and are monitored with a pulmonary artery catheter undergo two ventilation modes: 15 minutes of extra-thoracic negative pressure ventilation and usual intrathoracic positive-pressure ventilation. Hemodynamic parameters including right ventricular function, pulmonary artery pressures, and cardiac output are recorded via the pulmonary artery catheter and compared between the two modes. Patients with intraoperative complications, unstable circulation or ventilation, inability to fit the cuirass, or unavailable investigators are excluded. The protocol aims to determine immediate hemodynamic effects of changing intrathoracic pressure support in the early postoperative period.

Why it matters

Potential benefit: If successful, the approach could identify a ventilation method that reduces right ventricular strain and improves early hemodynamic stability after LVAD implantation.

How similar studies have gone: Negative pressure ventilation has been shown in prior small or historical studies to alter intrathoracic pressures and affect right-heart loading, but its specific application immediately after LVAD implantation is limited and relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Klinikum Karlsburg
    Karlsburg, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Using Apple Watch data to predict heart failure outcomes

    This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

    Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

  • Comparing Aortix Device to Diuretics for Acute Heart Failure

    This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

    Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

  • Predicting Extubation Problems With Machine Learning

    This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

    Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

  • Levetiracetam Dosing in Critically Ill on CRRT

    This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

    Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

  • Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

    Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

    Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

  • Tailored digital support to cut sedentary time in long-term cardiac rehab

    In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

    Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.