Ventricular Dysfunction, RightNCT07918690
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
An observational study of Ventricular Dysfunction, Right, run by Pınar Kırdemir at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left ventricular assist device (LVAD) implantation in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Dysfunction, Right
- What is being tested?
- Arterial Pulse Contour Analysis
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2026to Nov 2029
- Phase
- Observational
- 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
Study population: Adults aged 18 years or older with advanced heart failure who are scheduled for left ventricular assist device (LVAD) implantation at Ankara Bilkent City Hospital. Eligible patients of any sex will be consecutively enrolled during the study period.
Who may be able to join
- Age 18 years or older.
- Scheduled for left ventricular assist device (LVAD) implantation.
- Availability of the clinical data required for the study.
- Willingness and ability to provide informed consent.
Who cannot join
- Congenital heart disease associated with transposition of the great arteries.
- Ongoing extracorporeal membrane oxygenation (ECMO) or extracorporeal ventricular assist device (ExVAD) support immediately before LVAD implantation.
- Severe aortic regurgitation, severe peripheral arterial disease, or refractory and uncontrolled tachyarrhythmia that may interfere with arterial waveform analysis.
- Unwillingness to participate or cognitive impairment preventing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Pınar Kırdemir Gökkurt, MD, +905-348-2267-52, pinarkirdemir@gmail.com
About this study
Official title: Predictive Value of dPmax Measured by Pulse Contour Analysis for Postoperative Right Ventricular Failure in Patients Undergoing LVAD Implantation
This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left ventricular assist device (LVAD) implantation in adults. Measurements collected during routine monitoring before and after anesthesia induction will be analyzed alongside preoperative echocardiographic findings. The primary outcome is right ventricular failure within 30 days after surgery, assessed using Mechanical Circulatory Support-Academic Research Consortium (MCS-ARC) criteria. Secondary objectives include comparing the predictive performance of dPmax with the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/SPAP) and identifying an optimal dPmax threshold for predicting right ventricular failure. No additional invasive procedures will be performed for research purposes.
- Conditions
- Ventricular Dysfunction, Right
- Being tested
- Arterial Pulse Contour Analysis
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Pulse Contour AnalysisDiagnostic test
Arterial pulse contour analysis will be performed using the PulsioFlex monitoring system during routine invasive arterial monitoring for LVAD implantation. dPmax, representing the maximum rate of rise in arterial pressure, will be recorded before and after anesthesia induction. Absolute values and the relative change between measurements will be evaluated for their association with right ventricular failure within 30 days after surgery. No additional arterial catheterization or invasive procedures will be performed for research purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricular Failure Within 30 Days After LVAD Implantation
Measured: 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start3 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Dysfunction, RightStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pınar Kırdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pınar Kırdemir, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918690
- Sponsor's protocol ID
- TABED 1-26-2571
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of dPmax Measured by Pulse Contour Analysis for Postoperative Right Ventricular Failure in Patients Undergoing LVAD Implantation
- ClinicalTrials.gov ID
- NCT07918690
- Acronym / sponsor ID
- TABED 1-26-2571
- Conditions
- Ventricular Dysfunction, Right
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Pınar KırdemirUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left ventricular assist device (LVAD) implantation in adults. Measurements collected during routine monitoring before and after anesthesia induction will be analyzed alongside preoperative echocardiographic findings. The primary outcome is right ventricular failure within 30 days after surgery, assessed using Mechanical Circulatory Support-Academic Research Consortium (MCS-ARC) criteria. Secondary objectives include comparing the predictive performance of dPmax with the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/SPAP) and identifying an optimal dPmax threshold for predicting right ventricular failure. No additional invasive procedures will be performed for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with advanced heart failure who are scheduled for left ventricular assist device (LVAD) implantation at Ankara Bilkent City Hospital. Eligible patients of any sex will be consecutively enrolled during the study period.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Scheduled for left ventricular assist device (LVAD) implantation.
- Availability of the clinical data required for the study.
- Willingness and ability to provide informed consent.
Key exclusion criteria (4 listed)
- Congenital heart disease associated with transposition of the great arteries.
- Ongoing extracorporeal membrane oxygenation (ECMO) or extracorporeal ventricular assist device (ExVAD) support immediately before LVAD implantation.
- Severe aortic regurgitation, severe peripheral arterial disease, or refractory and uncontrolled tachyarrhythmia that may interfere with arterial waveform analysis.
- Unwillingness to participate or cognitive impairment preventing informed consent.
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 |
|---|---|---|
| Arterial Pulse Contour AnalysisArterial pulse contour analysis will be performed using the PulsioFlex monitoring system during routine invasive arterial monitoring for LVAD implantation. dPmax, representing the maximum rate of rise in arterial pressure, will be recorded before and after anesthesia induction. Absolute values and the relative change between measurements will be evaluated for their association with right ventricular failure within 30 days after surgery. No additional arterial catheterization or invasive procedures will be performed for research purposes. | Diagnostic test | – |
Primary outcome
Right Ventricular Failure Within 30 Days After LVAD Implantation
Time frame: 30 days after surgery.
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 5 Nov 2026.
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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?
An observational study of Ventricular Dysfunction, Right, run by Pınar Kırdemir at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 5 Nov 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Ventricular Failure Within 30 Days After LVAD Implantation (time frame: 30 days after surgery.). 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 5 Nov 2026.