Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

Medical University of Vienna24 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Late Complication From Cardiac Pacemaker Implantation

Interventions

RVAPOTHER

In this arm pacemaker leads will be placed in the RV apex.

RVSPOTHER

In this arm pacemaker leads will be placed in the RV septum.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiac Surgery, MUV

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: 6 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.