Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

Overview

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.

Full Title of Study: “Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2014

Interventions

  • Other: RVAP
    • In this arm pacemaker leads will be placed in the RV apex.
  • Other: RVSP
    • In this arm pacemaker leads will be placed in the RV septum.

Arms, Groups and Cohorts

  • Experimental: RVAP lead
    • 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.
  • Experimental: RVSP arm
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Ejection Fraction
    • Time Frame: 6 month
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • patients with dysrhythmia requiring dual-chamber pacemaker implantation – planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical) – age between 18-90 years – no absolute pacemaker dependence – no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography – LVH <15mm, LV EF>50%) – no previous myocardial infarction or significant coronary artery disease – life expectancy > 1 year – patients willing to participate in follow-up Exclusion criteria:

  • Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents) – Any contraindication for surgery – Absolute pacemaker dependence – Claustrophobia – GFR<30ml/min/1,73m2 – Allergy to contrast agent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alfred A Kocher, MD, MD., Prof. – Medical University of Vienna
  • Overall Official(s)
    • Alfred Kocher, MD, Principal Investigator, Department of Cardiac Surgery

References

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.

Cano O, Osca J, Sancho-Tello MJ, Sánchez JM, Ortiz V, Castro JE, Salvador A, Olagüe 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.

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. Epub 2011 May 20.

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