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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible patients - pacing mode sequence 1 | Experimental | Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-synchronous pacing mode first, then AV-dyssynchronous pacing mode. |
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| Eligible patients - pacing mode sequence 2 | Experimental | Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-dyssynchronous pacing mode first, then AV-synchronous pacing mode. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker stimulation mode | Other | Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | Echo parameters of diastolic function. | During echo examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | Echo parameters of systolic function. | During echo examination. |
| Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Steinwender, Assoc. Prof., MD | Kepler University Hospital, Department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Hospital | Linz | Upper Austria | 4020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37265566 | Derived | Blessberger H, Kammler J, Kellermair J, Kiblboeck D, Nahler A, Hrncic D, Saleh K, Schwarz S, Reiter C, Fellner A, Eppacher C, Sheldon TJ, Steinwender C. Impact of pacing mode and different echocardiographic parameters on cardiac output (PADIAC). Front Cardiovasc Med. 2023 May 17;10:1185518. doi: 10.3389/fcvm.2023.1185518. eCollection 2023. |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
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It is decided by coin tossing which pacing mode is programmed first (randomization). Sonographer and patient are both blinded to the pacing mode.
Echo parameters of atrial function. |
| During echo examination. |
| Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. | Demographic variables and co-morbidities. | During echo examination. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |