Status:
COMPLETED
Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Abbott Medical Devices
British Heart Foundation
Conditions:
Ventricular Dysfunction
Ventricular Remodelling
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01842243
Start Date
February 1 2012
End Date
December 31 2015
Last Update
February 4 2019
Active Locations (1)
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1
University Hospital of South Manchester NHS trust
Manchester, United Kingdom, M23 9LT