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

NCT ID: NCT01842243

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Apical Pacing

Pacemaker programmed to pacing the heart at apex for 9 months.

Group Type: ACTIVE_COMPARATOR

Apical pacing

Intervention Type: PROCEDURE

Pacemaker set to pace at right ventricular apex initially.

Septal pacing

Intervention Type: PROCEDURE

Pacemaker set to pace at right ventricular septum initially.

Pacemaker

Intervention Type: DEVICE

MR conditional Pacemaker implanted in all study patients

Septal Pacing

Pacemaker programmed to pacing the heart at the septum for 9 months.

Group Type: ACTIVE_COMPARATOR

Apical pacing

Intervention Type: PROCEDURE

Pacemaker set to pace at right ventricular apex initially.

Septal pacing

Intervention Type: PROCEDURE

Pacemaker set to pace at right ventricular septum initially.

Pacemaker

Intervention Type: DEVICE

MR conditional Pacemaker implanted in all study patients

Interventions

Apical pacing

Pacemaker set to pace at right ventricular apex initially.

Intervention Type: PROCEDURE

Septal pacing

Pacemaker set to pace at right ventricular septum initially.

Intervention Type: PROCEDURE

Pacemaker

MR conditional Pacemaker implanted in all study patients

Intervention Type: DEVICE

Other Intervention Names

MR conditional Pacemaker

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

British Heart Foundation

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Dr Ainslie, MBChB

Role: PRINCIPAL_INVESTIGATOR

University Hospital of South Manchester

Locations

University Hospital of South Manchester NHS trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011CD016

Identifier Type: -

Identifier Source: org_study_id