Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment

NCT05575557

Heart Failure With Reduced Ejection Fraction Atrial Fibrillation, Persistent Sick Sinus Syndrome +1 more

UNKNOWN NA

Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

NCT03147027

Ventricular Tachycardia Ischemic Cardiomyopathy Reduced LVEF

UNKNOWN

Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

NCT01088308

Arrhythmias, Cardiac

TERMINATED NA

Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

NCT04747353

Ventricular Tachycardia

COMPLETED NA

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

NCT05106491

Cardiogenic Shock Extracorporeal Membrane Oxygenation ECLS +1 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies?
* How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies?
* How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography?
* How do PiCCO cardiac function variables (GEF \[global ejection fraction\]; CFI \[cardiac function index\]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)?
* How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)?
* How does right ventricular function influence GEDV, GEF and CFI?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LV-EF > 50%

PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\]

Group Type EXPERIMENTAL

PiCCO Catheter (Pulsiocath 5F)

Intervention Type DEVICE

Measuring of PiCCO derived values

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PiCCO Catheter (Pulsiocath 5F)

Measuring of PiCCO derived values

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\] (n=10, control group)
* Coronary heart disease with impaired left ventricular function \[LV-EF \< 50%\] (n=10)
* Dilated cardiomyopathy (n=10),
* Aortic valve stenosis (n=10),
* Mitral valve regurgitation (n=10),
* Diastolic left ventricular dysfunction (n=10) and
* Right heart failure (n=10)

Exclusion Criteria

* Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included.
* Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study.
* The age does not represent an exclusion criterion.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No