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

NCT01842243 | Completed DMC

• 1 other identifier: 2011CD016
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

Ventricular dysfunction; MRI; Echocardiography; Pacemakers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Levels of BNP

  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

Study Arms (2)

Apical Pacing

ACTIVE COMPARATOR

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

Procedure: Apical pacing; Procedure: Septal pacing; Device: Pacemaker

Septal Pacing

ACTIVE COMPARATOR

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

Procedure: Apical pacing; Procedure: Septal pacing; Device: Pacemaker

Interventions

Apical pacing PROCEDURE

Pacemaker set to pace at right ventricular apex initially.

Apical Pacing; Septal Pacing

Septal pacing PROCEDURE

Pacemaker set to pace at right ventricular septum initially.

Apical Pacing; Septal Pacing

Pacemaker DEVICE

MR conditional Pacemaker implanted in all study patients

Also known as: MR conditional Pacemaker

Apical Pacing; Septal Pacing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Abbott Medical Devices: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

University Hospital of South Manchester NHS trust

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Ventricular Dysfunction; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Dr Ainslie, MBChB

  University Hospital of South Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: February 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: February 4, 2019

Record last verified: 2013-01

Locations

GB (1)