Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias
NCT ID: NCT03151278
Last Updated: 2023-11-24
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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COMPLETED
NA
212 participants
INTERVENTIONAL
2011-01-31
2018-12-31
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 three-dimensional mapping systems such as Ensite NavX have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.
Ensite NavX is a promising system to guide catheters inside the cardiac chambers and vessels without the use of fluoroscopy.
This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zero-fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy.
Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
Conventional fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system.
Conventional fluoroscopy ablation
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Interventions
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Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
Conventional fluoroscopy ablation
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Eligibility Criteria
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Inclusion Criteria
* Atrial Premature Complexes
Exclusion Criteria
* Left Atrial Tachycardia
18 Years
90 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Xinyang Central Hospital
OTHER
Ningbo No. 1 Hospital
OTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Shenzhen Sun Yat-sen Cardiovascular Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Zhongshan Hospital Xiamen University
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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References
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Gelsomino S, La Meir M, Luca F, Lorusso R, Crudeli E, Vasquez L, Gensini GF, Maessen J. Treatment of lone atrial fibrillation: a look at the past, a view of the present and a glance at the future. Eur J Cardiothorac Surg. 2012 Jun;41(6):1284-94. doi: 10.1093/ejcts/ezr222. Epub 2012 Jan 10.
Birnie D, Healey JS, Krahn AD, Ahmad K, Crystal E, Khaykin Y, Chauhan V, Philippon F, Exner D, Thibault B, Hruczkowski T, Nery P, Keren A, Redfearn D. Prevalence and risk factors for cervical and lumbar spondylosis in interventional electrophysiologists. J Cardiovasc Electrophysiol. 2011 Sep;22(9):957-60. doi: 10.1111/j.1540-8167.2011.02041.x. Epub 2011 Mar 8.
Sra J, Krum D, Hare J, Okerlund D, Thompson H, Vass M, Schweitzer J, Olson E, Foley WD, Akhtar M. Feasibility and validation of registration of three-dimensional left atrial models derived from computed tomography with a noncontact cardiac mapping system. Heart Rhythm. 2005 Jan;2(1):55-63. doi: 10.1016/j.hrthm.2004.10.035.
Oral H, Crawford T, Frederick M, Gadeela N, Wimmer A, Dey S, Sarrazin JF, Kuhne M, Chalfoun N, Wells D, Good E, Jongnarangsin K, Chugh A, Bogun F, Pelosi F Jr, Morady F. Inducibility of paroxysmal atrial fibrillation by isoproterenol and its relation to the mode of onset of atrial fibrillation. J Cardiovasc Electrophysiol. 2008 May;19(5):466-70. doi: 10.1111/j.1540-8167.2007.01089.x. Epub 2008 Feb 4.
Razminia M, Manankil MF, Eryazici PL, Arrieta-Garcia C, Wang T, D'Silva OJ, Lopez CS, Crystal GJ, Khan S, Stancu MM, Turner M, Anthony J, Zheutlin TA, Kehoe RF. Nonfluoroscopic catheter ablation of cardiac arrhythmias in adults: feasibility, safety, and efficacy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1078-86. doi: 10.1111/j.1540-8167.2012.02344.x. Epub 2012 May 9.
Other Identifiers
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TJHCDD-ZF-RAA-20110131
Identifier Type: -
Identifier Source: org_study_id