Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI (MAPS)
Primary Purpose
Ventricular Dysfunction, Ventricular Remodelling
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Apical pacing
Septal pacing
Pacemaker
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Dysfunction focused on measuring Ventricular dysfunction, MRI, Echocardiography, Pacemakers
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.
Sites / Locations
- University Hospital of South Manchester NHS trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Apical Pacing
Septal Pacing
Arm Description
Pacemaker programmed to pacing the heart at apex for 9 months.
Pacemaker programmed to pacing the heart at the septum for 9 months.
Outcomes
Primary Outcome Measures
Ventricular Ejection fraction
Comparison of % change in Left and Right Ventricular Ejection Fractions between apical and septal pacing groups as measured on MRI.
Secondary Outcome Measures
Levels of BNP
Blood Sampling
MRI measures of Left and Right ventricular dyssynchrony
Exercise Capacity as measured by CPEX
6 minute walk tests
Quality of life measures SF36
Level of Pro-BNP
Blood sampling
Level of ICTP
Blood sampling
Level of MMP-1
Blood sampling
Level of MMP2
Blood sampling
Level of MMP-9
Blood sampling
Level of Troponin
Blood sampling
Level of GDF-15
Blood sampling
Full Information
NCT ID
NCT01842243
First Posted
April 24, 2013
Last Updated
February 1, 2019
Sponsor
Manchester University NHS Foundation Trust
Collaborators
Abbott Medical Devices, British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01842243
Brief Title
Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI
Acronym
MAPS
Official Title
Multiparametric CMR Assessment of Apical Versus Septal Pacing Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
Abbott Medical Devices, British Heart Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Dysfunction, Ventricular Remodelling
Keywords
Ventricular dysfunction, MRI, Echocardiography, Pacemakers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apical Pacing
Arm Type
Active Comparator
Arm Description
Pacemaker programmed to pacing the heart at apex for 9 months.
Arm Title
Septal Pacing
Arm Type
Active Comparator
Arm Description
Pacemaker programmed to pacing the heart at the septum for 9 months.
Intervention Type
Procedure
Intervention Name(s)
Apical pacing
Intervention Description
Pacemaker set to pace at right ventricular apex initially.
Intervention Type
Procedure
Intervention Name(s)
Septal pacing
Intervention Description
Pacemaker set to pace at right ventricular septum initially.
Intervention Type
Device
Intervention Name(s)
Pacemaker
Other Intervention Name(s)
MR conditional Pacemaker
Intervention Description
MR conditional Pacemaker implanted in all study patients
Primary Outcome Measure Information:
Title
Ventricular Ejection fraction
Description
Comparison of % change in Left and Right Ventricular Ejection Fractions between apical and septal pacing groups as measured on MRI.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Levels of BNP
Description
Blood Sampling
Time Frame
18 months
Title
MRI measures of Left and Right ventricular dyssynchrony
Time Frame
18 months
Title
Exercise Capacity as measured by CPEX
Time Frame
18 months
Title
6 minute walk tests
Time Frame
18 months
Title
Quality of life measures SF36
Time Frame
18 months
Title
Level of Pro-BNP
Description
Blood sampling
Time Frame
18 months
Title
Level of ICTP
Description
Blood sampling
Time Frame
18 months
Title
Level of MMP-1
Description
Blood sampling
Time Frame
18 months
Title
Level of MMP2
Description
Blood sampling
Time Frame
18 months
Title
Level of MMP-9
Description
Blood sampling
Time Frame
18 months
Title
Level of Troponin
Description
Blood sampling
Time Frame
18 months
Title
Level of GDF-15
Description
Blood sampling
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Dr Ainslie, MBChB
Organizational Affiliation
University Hospital of South Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of South Manchester NHS trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
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Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI
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