Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01682239

Enrollment

Registered

2012-09-10

Start date

2012-09-30

Completion date

2015-08-31

Last updated

2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Complication From Cardiac Pacemaker Implantation

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.

Interventions

OTHERRVAP

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

OTHERRVSP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026