Clinical trial NCT01682239: Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
Official title: Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Late Complication From Cardiac Pacemaker Implantation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.


Eligibility criteria: Inclusion criteria:

* patients with dysrhythmia requiring dual-chamber pacemaker implantation
* planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
* age between 18-90 years
* no absolute pacemaker dependence
* no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH \<15mm, LV EF\>50%)
* no previous myocardial infarction or significant coronary artery disease
* life expectancy \> 1 year
* patients willing to participate in follow-up

Exclusion criteria:

* Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
* Any contraindication for surgery
* Absolute pacemaker dependence
* Claustrophobia
* GFR\<30ml/min/1,73m2
* Allergy to contrast agent

Primary outcomes:
measure: Ejection Fraction
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Cardiac Surgery, MUV
Study officials:
affiliation: Department of Cardiac Surgery
name: Alfred Kocher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2.
citation: Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30.
citation: Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20.