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Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVAP lead | Experimental | Pacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy. |
|
| RVSP arm | Experimental | Pacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVAP | Other | In this arm pacemaker leads will be placed in the RV apex. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection Fraction | As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum. | 6 month |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfred Kocher, MD | Department of Cardiac Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac Surgery, MUV | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22851216 | Background | Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2. | |
| 20451689 | Background | Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30. |
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| RVSP |
| Other |
In this arm pacemaker leads will be placed in the RV septum. |
|
| 21597204 | Background | Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20. |