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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Ventricular Dysfunction
Ventricular Remodelling
Procedure: Apical pacing
Procedure: Septal pacing
Device: Pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Multiparametric CMR Assessment of Apical Versus Septal Pacing Study

Further study details as provided by University Hospital of South Manchester NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apical Pacing
Pacemaker programmed to pacing the heart at apex for 9 months.
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: Septal Pacing
Pacemaker programmed to pacing the heart at the septum for 9 months.
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842243

Contacts
Contact: Matthias Schmitt, MD PHD 0161 2914563 matthias.schmitt@uhsm.nhs.uk
Contact: Mark P Ainslie, MBChB markainslie@nhs.net

Locations
United Kingdom
University Hospital of South Manchester NHS trust Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Matthias Schmitt, MD PHD       matthias.schmitt@uhsm.nhs.uk   
Contact: Mark P Ainslie, MBChB       markainslie@nhs.net   
Principal Investigator: Mark P Ainslie, MBChB         
Sponsors and Collaborators
University Hospital of South Manchester NHS Foundation Trust
St. Jude Medical
British Heart Foundation
Investigators
Principal Investigator: Mark Dr Ainslie, MBChB University Hospital of South Manchester
  More Information

No publications provided

Responsible Party: University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01842243     History of Changes
Other Study ID Numbers: 2011CD016
Study First Received: April 24, 2013
Last Updated: April 29, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital of South Manchester NHS Foundation Trust:
Ventricular dysfunction
MRI
Echocardiography
Pacemakers

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Remodeling
Cardiovascular Diseases
Heart Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 30, 2014