Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Alfred A Kocher, MD, Medical University of Vienna
First received: September 6, 2012
Last updated: September 7, 2012
Last verified: September 2012
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.
Late Complication From Cardiac Pacemaker Implantation
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
||Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial
Primary Outcome Measures:
- Ejection Fraction [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Experimental: RVAP lead
Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
In this arm pacemaker leads will be placed in the RV apex.
Experimental: RVSP arm
Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
In this arm pacemaker leads will be placed in the RV septum.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
- Any contraindication for surgery
- Absolute pacemaker dependence
- Allergy to contrast agent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01682239
|Department of Cardiac Surgery, MUV
|Vienna, Austria, 1090 |
Medical University of Vienna
||Alfred Kocher, MD
||Department of Cardiac Surgery
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.
ClinicalTrials.gov processed this record on May 24, 2016
||Alfred A Kocher, MD, MD., Prof., Medical University of Vienna
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 6, 2012
||September 7, 2012
||Austria: Agency for Health and Food Safety