Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
NCT ID: NCT03118440
Last Updated: 2017-04-18
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
100 participants
INTERVENTIONAL
2013-01-31
2020-12-31
Brief Summary
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Detailed Description
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Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.
Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zero-fluoroscopy implantation
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
zero-fluoroscopy 3D navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
Conventional fluoroscopy implantation
Pacemaker implantation performed for all patients with conventional x-ray navigation.
conventional x-ray navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Interventions
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zero-fluoroscopy 3D navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
conventional x-ray navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* complete Atrioventricular Block
* high degree second Degree Atrioventricular Block
* Bradycardia
Exclusion Criteria
* severe structural l cardiac malformations
* severe cardiac enlargement
* venous malformations
18 Years
90 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Xinyang Central Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
Wuhan Asia Heart Hospital
OTHER
Shenzhen Sun Yat-sen Cardiovascular Hospital
OTHER
Ningbo No. 1 Hospital
OTHER
Tongji Hospital
OTHER
Responsible Party
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Yan Wang
Professor
Principal Investigators
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Yan Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vano E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology. 2010 Nov;257(2):321-32. doi: 10.1148/radiol.10091269.
Ventura R, Rostock T, Klemm HU, Lutomsky B, Demir C, Weiss C, Meinertz T, Willems S. Catheter ablation of common-type atrial flutter guided by three-dimensional right atrial geometry reconstruction and catheter tracking using cutaneous patches: a randomized prospective study. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1157-61. doi: 10.1046/j.1540-8167.2004.04064.x.
Gepstein L, Hayam G, Ben-Haim SA. A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results. Circulation. 1997 Mar 18;95(6):1611-22. doi: 10.1161/01.cir.95.6.1611.
Lemery R. Interventional electrophysiology at the crossroads: cardiac mapping, ablation and pacing without fluoroscopy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1087-91. doi: 10.1111/j.1540-8167.2012.02373.x. Epub 2012 Aug 6. No abstract available.
Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.
Wittkampf FH, Wever EF, Derksen R, Wilde AA, Ramanna H, Hauer RN, Robles de Medina EO. LocaLisa: new technique for real-time 3-dimensional localization of regular intracardiac electrodes. Circulation. 1999 Mar 16;99(10):1312-7. doi: 10.1161/01.cir.99.10.1312.
Schreieck J, Ndrepepa G, Zrenner B, Schneider MA, Weyerbrock S, Dong J, Schmitt C. Radiofrequency ablation of cardiac arrhythmias using a three-dimensional real-time position management and mapping system. Pacing Clin Electrophysiol. 2002 Dec;25(12):1699-707. doi: 10.1046/j.1460-9592.2002.01699.x.
Other Identifiers
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TJHCDC-ZF-PMSC-20130101
Identifier Type: -
Identifier Source: org_study_id
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