Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI

Summary

Despite considerable effort the optimal site to place a pacemaker lead at the time of pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated with an increase in heart rhythm problems and also heart failure (impaired pumping function). The top of the ventricle (septum) has been investigated as an alternative site and is now routinely used by some centres. Previous estimation of the hearts pumping function (ejection fraction) has been limited to the use of echo (sound waves). Echo is not sensitive enough to detect small changes in the ejection fraction reliably (measure of pumping function of heart). The gold standard for measurement of ejection fraction is MRI (using magnets). Previous pacemakers have not been compatible with MRI scans. The latest generation of pacemakers are now able to be safely scanned within an MRI scanner. This allows a much more accurate estimation of the effects of a pacemaker on the ejection fraction which has not yet been studied.

The investigators plan to study those patients undergoing a pacemaker implant and ablation procedure as part of their standard care.

Individuals will have an exercise test, blood test used to measure biomarkers and fill in a symptom questionnaire.

Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will be inserted, one apically and one septally. Only one lead will be used at any given time. Individuals will then undergo their planned AV node ablation.

Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9 and 18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart muscle strain, exercise testing and echocardiograms.

The hypothesis is that a lead placed on the septum will produce superior cardiac performance over the short and long term.

Conditions

• Ventricular Dysfunction
• Ventricular Remodelling

Interventions

PROCEDURE

Apical pacing

Pacemaker set to pace at right ventricular apex initially.

PROCEDURE

Septal pacing

Pacemaker set to pace at right ventricular septum initially.

DEVICE

Pacemaker

MR conditional Pacemaker implanted in all study patients

Sponsors & Collaborators

• Abbott Medical Devices

  collaborator INDUSTRY

• British Heart Foundation

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Mark Dr Ainslie, MBChB · University Hospital of South Manchester

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United Kingdom

Study Locations