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

Multiparametric CMR Assessment of Apical Versus Septal Pacing Study

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Dysfunction; Ventricular Remodelling
• Intervention / Treatment: Procedure: Apical pacing; Procedure: Septal pacing; Device: Pacemaker

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • University Hospital of South Manchester NHS trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in permanent Atrial Fibrillation (AF)requiring a pacemaker on clinical grounds (tachycardia/bradycardia syndrome or requiring an AV node ablation)and AV node ablation or a pacemaker for rate control)
• Patients aged 18 to 85 years old.
• Able to consent for study.

Exclusion Criteria:

• Patients with moderate to severe LV dysfunction (EF < 40%).
• Any contraindication to an MRI scan.
• Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
• Patients with a Myocardial Infarction within three months prior to enrollment.
• Patients that received bypass surgery within three months prior to enrollment.
• Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve.
• Patients where a right ventricular lead cannot be placed e.g. complex congenital heart disease.
• Patients with hypertrophic obstructive cardiomyopathy.
• Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or haemodynamically significant aortic stenosis.
• Previous implanted pacemaker or cardioverter defibrillator.
• Terminal conditions with a life expectancy of less than two years.
• Participation in any other study that would confound the results of this study.
• Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study.
• Pregnant patients or patients who may become pregnant during the time-scale of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apical Pacing; Pacemaker programmed to pacing the heart at apex for 9 months.	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; Other Names: MR conditional Pacemaker
Active Comparator: Septal Pacing; Pacemaker programmed to pacing the heart at the septum for 9 months.	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; Other Names: MR conditional Pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular Ejection fraction	Comparison of % change in Left and Right Ventricular Ejection Fractions between apical and septal pacing groups as measured on MRI.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of BNP	Blood Sampling	18 months
MRI measures of Left and Right ventricular dyssynchrony		18 months
Exercise Capacity as measured by CPEX		18 months
6 minute walk tests		18 months
Quality of life measures SF36		18 months
Level of Pro-BNP	Blood sampling	18 months
Level of ICTP	Blood sampling	18 months
Level of MMP-1	Blood sampling	18 months
Level of MMP2	Blood sampling	18 months
Level of MMP-9	Blood sampling	18 months
Level of Troponin	Blood sampling	18 months
Level of GDF-15	Blood sampling	18 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Abbott Medical Devices; British Heart Foundation
• Investigators: Principal Investigator: Mark Dr Ainslie, MBChB, University Hospital of South Manchester

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: MRI; Echocardiography; Pacemakers; Ventricular dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Ventricular Dysfunction; Ventricular Remodeling
• Other Study ID Numbers: 2011CD016