An interventional study of Zero-fluoroscopy ablation and Conventional fluoroscopy ablation in Atrial Arrhythmia, Atrial Premature Complexes and Atrial Tachycardia, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Atrial Premature Complexes; 6 are open to participants now.
This study's enrollment of 212 is above the median of 112 across 14 interventional studies indexed under Atrial Premature Complexes.
Browse Atrial Premature Complexes studies →Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy.
Procedure: Zero-fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Total success rates
The patients have no related arrhythias or recurrence during follow up.
Time frame: 3 months
Total procedure time
The patients have no related arrhythias or recurrence during follow up.
Time frame: during procedure
Fluoroscopy time
From skin puncture to withdrawal of all the catheters.
Time frame: during procedure
Complications
The patients have no related complications during follow up.
Time frame: 6 months
Immediate success rate
Electrophysiologic study shows success of ablation
Time frame: 24 hours
Recurrence rate
The patients have no related arrhythias or recurrence during follow up.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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