AV Block, Cardiac Output, Diastolic Function, Pacemaker Stimulation Mode, Stroke Volume
Conditions
Keywords
Diastolic function, Cardiac output, Pacemaker stimulation mode, Stroke volume
Brief summary
Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially. Aim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes. Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.
Interventions
OTHERPacemaker stimulation mode
Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.
Sponsors
Medtronic
Kepler University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
It is decided by coin tossing which pacing mode is programmed first (randomization). Sonographer and patient are both blinded to the pacing mode.
Intervention model description
Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient is able and willing to give informed consent and is above the age of 18. * Patient is implanted with a dual chamber pacemaker system for at least 6 weeks. * Patient is in sinus rhythm on the day of recruitment. * Patient has a ventricular pacing rate exceeding 90%. * Upon initial device interrogation, parameters are within normal ranges. * Calculated battery life is more than 1 year.
Exclusion criteria
* Patient is not in sinus rhythm on the day of echo examination. * Intrinsic ventricular activation on the day of echo examination. * Relevant shunt on the atrial, ventricular or pulmonary level. * Moderate or severe heart valve dysfunction (stenosis or regurgitation). * Presence of other medical devices that may interact with the pacemaker system. * Women who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | During echo examination. | Echo parameters of diastolic function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | During echo examination. | Echo parameters of systolic function. |
| Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | During echo examination. | Echo parameters of atrial function. |
| Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | During echo examination. | Demographic variables and co-morbidities. |
Countries
Austria
Outcome results
None listed