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

This study is currently recruiting participants.
Verified January 2013 by University Hospital of South Manchester NHS Foundation Trust
Sponsor:
Collaborators:
St. Jude Medical
British Heart Foundation
Information provided by (Responsible Party):
University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01842243
First received: April 24, 2013
Last updated: April 29, 2013
Last verified: January 2013

April 24, 2013
April 29, 2013
February 2012
August 2016   (final data collection date for primary outcome measure)
Ventricular Ejection fraction [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Comparison of % change in Left and Right Ventricular Ejection Fractions between apical and septal pacing groups as measured on MRI.
Same as current
Complete list of historical versions of study NCT01842243 on ClinicalTrials.gov Archive Site
  • Levels of BNP [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood Sampling
  • MRI measures of Left and Right ventricular dyssynchrony [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Exercise Capacity as measured by CPEX [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 6 minute walk tests [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of life measures SF36 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Level of Pro-BNP [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of ICTP [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of MMP-1 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of MMP2 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of MMP-9 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of Troponin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Level of GDF-15 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Blood sampling
  • Levels of BNP, Pro BNP, ICTP, MMP 1,2 & 9, GDF 15 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • MRI measures of Left and Right ventricular dyssynchrony [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Exercise Capacity as measured by CPEX [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 6 minute walk tests [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of life measures SF36 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
  • Ventricular Dysfunction
  • Ventricular Remodelling
  • 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 Name: MR conditional Pacemaker
  • Active Comparator: Apical Pacing
    Pacemaker programmed to pacing the heart at apex for 9 months.
    Interventions:
    • Procedure: Apical pacing
    • Procedure: Septal pacing
    • Device: Pacemaker
  • Active Comparator: Septal Pacing
    Pacemaker programmed to pacing the heart at the septum for 9 months.
    Interventions:
    • Procedure: Apical pacing
    • Procedure: Septal pacing
    • Device: Pacemaker
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2016
August 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Matthias Schmitt, MD PHD 0161 2914563 matthias.schmitt@uhsm.nhs.uk
Contact: Mark P Ainslie, MBChB markainslie@nhs.net
United Kingdom
 
NCT01842243
2011CD016
Yes
University Hospital of South Manchester NHS Foundation Trust
University Hospital of South Manchester NHS Foundation Trust
  • St. Jude Medical
  • British Heart Foundation
Principal Investigator: Mark Dr Ainslie, MBChB University Hospital of South Manchester
University Hospital of South Manchester NHS Foundation Trust
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP