Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

Medical University of Vienna

Status: Unknown

Conditions: Late Complication From Cardiac Pacemaker Implantation

Treatments: Other: RVAP; Other: RVSP

Study type: Interventional

Funder types: Other

Identifiers

NCT01682239

EC 023/2012

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

RVAP lead

Experimental group

Description:

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.

Treatment:

Other: RVAP

RVSP arm

Experimental group

Description:

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.

Treatment:

Other: RVSP