Late Complication From Cardiac Pacemaker Implantation Clinical Trial
Official title:
Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial
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.
| Status | Enrolling by invitation |
| Enrollment | 24 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Cardiac Surgery, MUV | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
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. — View Citation
Cano O, Osca J, Sancho-Tello MJ, Sánchez JM, Ortiz V, Castro JE, Salvador A, Olagüe 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. — View 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. Epub 2011 May 20. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ejection Fraction | As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum. | 6 month | Yes |