Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

Not Applicable

• Conditions: Late Complication From Cardiac Pacemaker Implantation
• Interventions: Other: RVAP; Other: RVSP

• Registration Number: NCT01682239
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-09-07
• Last Update Submitted: 2012-09-07
• Study First Posted: 2012-09-10
• Last Update Posted: 2012-09-10
• Primary Completion: 2014-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RVAP lead	RVAP	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	RVSP	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.

Primary Outcome Measures

Name	Time	Method
Ejection Fraction	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.

Trial Locations

Locations (1)

Department of Cardiac Surgery, MUV; 🇦🇹 Vienna, Austria