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Search for the Optimal Right Ventricular Pacing Site: Design and Implementation of Three Randomized Multicenter Clinical Trials

Authors


  • Dr. Kaye has delivered paid lectures and has received grant support from Medtronic and Biotronik; Dr. Stambler has received grant support, honoraria, and consultant fees from Medtronic, Boston Scientific, St. Jude Medical, and Biotronik. Dr. Yee is an independent consultant for Medtronic and has served as a paid speaker for Medtronic and St. Jude.

Address for reprints: Bruce S. Stambler, M.D., University Hospitals of Cleveland, Division of Cardiology, 11100 Euclid Avenue, Cleveland, OH 44106. Fax: 216-844-7116; e-mail: bss4@cwru.edu

Abstract

Background: The optimal site to permanently pace the right ventricle (RV) has yet to be determined. To address this issue, three randomized prospective multicenter clinical trials are in progress comparing the long-term effects of RV apical versus septal pacing on left ventricular (LV) function. The three trials are Optimize RV Selective Site Pacing Clinical Trial (Optimize RV), Right Ventricular Apical and High Septal Pacing to Preserve Left Ventricular Function (Protect Pace), and Right Ventricular Apical versus Septal Pacing (RASP).

Methods: Patients that require frequent or continuous ventricular pacing are randomized to RV apical or septal pacing. Optimize RV excludes patients with LV ejection fraction <40% prior to implantation, whereas the other trials include patients regardless of baseline LV systolic function. The RV septal lead is positioned in the mid-septum in Optimize RV, the high septum in Protect Pace, and the mid-septal inflow tract in RASP. Lead position is confirmed by fluoroscopy in two planes and adjudicated by a blinded panel. The combined trials will follow approximately 800 patients for up to 3 years.

Results: The primary outcome in each trial is LV ejection fraction evaluated by radionuclide ventriculography or echocardiography. Secondary outcomes include echo-based measurements of ventricular/atrial remodeling, 6-minute hall walk distance, brain natriuretic peptide levels, and clinical events (atrial tachyarrhythmias, heart failure, stroke, or death).

Conclusion: These selective site ventricular pacing trials should provide evidence of the importance of RV pacing site in the long-term preservation of LV function in patients that require ventricular pacing and help to clarify the optimal RV pacing site.

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