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

Ventricular Dysfunction Clinical Trial

— MAPS  

Official title:

Multiparametric CMR Assessment of Apical Versus Septal Pacing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842243
• Other study ID #: 2011CD016
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: January 2013
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ventricular Dysfunction
• Ventricular Remodeling
• Ventricular Remodelling

Intervention

Procedure:
• Apical pacing
Pacemaker set to pace at right ventricular apex initially.
• Septal pacing
Pacemaker set to pace at right ventricular septum initially.

Device:
• Pacemaker
MR conditional Pacemaker implanted in all study patients

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester NHS trust	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Abbott Medical Devices, British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

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