Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
NCT ID: NCT01682239
Last Updated: 2012-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2012-09-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
RVAP
In this arm pacemaker leads will be placed in the RV apex.
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.
RVSP
In this arm pacemaker leads will be placed in the RV septum.
Interventions
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RVAP
In this arm pacemaker leads will be placed in the RV apex.
RVSP
In this arm pacemaker leads will be placed in the RV septum.
Eligibility Criteria
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Inclusion Criteria
* 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
* Any contraindication for surgery
* Absolute pacemaker dependence
* Claustrophobia
* GFR\<30ml/min/1,73m2
* Allergy to contrast agent
18 Years
90 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Alfred A Kocher, MD
MD., Prof.
Principal Investigators
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Alfred Kocher, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac Surgery
Locations
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Department of Cardiac Surgery, MUV
Vienna, Vienna, Austria
Countries
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References
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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.
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.
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.
Other Identifiers
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EC 023/2012
Identifier Type: -
Identifier Source: org_study_id