Critical IllnessNPV LVADNCT07034599
Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.
A study testing Negative pressure ventilation and positive pressure ventilation in people with Critical Illness and Heart Failure, run by Karlsburg Hospital at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Heart Failure, LVAD
- What is being tested?
- Negative pressure ventilation and positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients after implantation of a durable left ventricular assist device
Who cannot join
- Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Karlsburg
Karlsburg
Matthias Heringlake, Prof. Dr. Med., 004938355702500, aneathesie.karlsburg@drguth.de
About this study
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.
- Conditions
- Critical Illness, Heart Failure, LVAD
- Being tested
- Negative pressure ventilation, positive pressure ventilation
- Medical subject headings
- Critical Illness, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure ventilationDevice
All participants are ventilated with negative pressure ventilation first
positive pressure ventilationDevice
All participants are ventilated using positive pressure ventilation after negative pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| All participants negative pressure ventilation and positive pressure ventilation | Experimental | Not described Receives: Device: Negative pressure ventilation; Device: positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RVSWI
right ventricular stroke work index
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlsburg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg
- Responsible party
- Principal investigator, Prof. Dr. Matthias Heringlake, Karlsburg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034599
- Sponsor's protocol ID
- KAIKB 2025-2
- Acronym
- NPV LVAD
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.
- ClinicalTrials.gov ID
- NCT07034599
- Acronym / sponsor ID
- NPV LVAD / KAIKB 2025-2
- Conditions
- Critical Illness, Heart Failure, LVAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karlsburg HospitalUniversity, hospital or other
- Collaborators
- University Hospital Freiburg
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants negative pressure ventilation and positive pressure ventilation | Experimental | Device: Negative pressure ventilation, Device: positive pressure ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients after implantation of a durable left ventricular assist device
Key exclusion criteria (1 listed)
- Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure ventilationAll participants are ventilated with negative pressure ventilation first | Device | All participants negative pressure ventilation and positive pressure ventilation |
| positive pressure ventilationAll participants are ventilated using positive pressure ventilation after negative pressure ventilation | Device | All participants negative pressure ventilation and positive pressure ventilation |
Primary outcome
RVSWI
Time frame: one minute
right ventricular stroke work index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure ventilation and positive pressure ventilation in people with Critical Illness and Heart Failure, run by Karlsburg Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Heringlake, Prof. Dr. med. (038355 70-2500, Heringlake@drguth.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RVSWI (time frame: one minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.