Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias (ZFA-RAA)
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|ClinicalTrials.gov Identifier: NCT03151278|
Recruitment Status : Unknown
Verified May 2017 by Yan Wang, Tongji Hospital.
Recruitment status was: Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Arrhythmia Atrial Premature Complexes Atrial Tachycardia||Procedure: Zero-fluoroscopy ablation Procedure: Conventional fluoroscopy ablation||Not Applicable|
Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for the Ablation of Right Atrial Arrhythmias|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Zero-fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under the guidance of Ensite NavX without fluoroscopy.
Procedure: Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
Active Comparator: Conventional fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under the guidance of X-ray plus any tree dimensional mapping system.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
- Total success rates [ Time Frame: 3 months ]
- Total procedure time [ Time Frame: during procedure ]
- Fluoroscopy time [ Time Frame: during procedure ]
- Complications [ Time Frame: 6 months ]
- Immediate success rate [ Time Frame: 24 hours ]
- Recurrence rate [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151278
|Contact: Yan Wang, PhDfirstname.lastname@example.org|
|Contact: Guangzhi Chen, PhDemail@example.com|
|Wuhan, Hubei, China, 430030|
|Contact: Yan Wang, PhD +86-13697326307 firstname.lastname@example.org|
|Contact: Guangzhi Chen, PhD 86-27-83662842 email@example.com|
|Principal Investigator:||Yan Wang, PhD||Tongji Hospital|