Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial

Conditions
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Late Complication From Cardiac Pacemaker Implantation

Intervention / Treatment
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* Other: RVAP
* Other: RVSP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVAP lead<br>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. | Other: RVAP<br>* In this arm pacemaker leads will be placed in the RV apex.<br>|
| Experimental: RVSP arm<br>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. | Other: RVSP<br>* In this arm pacemaker leads will be placed in the RV septum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |