Atrial Arrhythmia, Atrial Premature Complexes, Atrial Tachycardia
Conditions
Keywords
Fluoroscopy, Ablation, Three dimensional, Atrial arrhythmia, Radiation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREZero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
PROCEDUREConventional fluoroscopy ablation
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Sponsors
Fu Wai Hospital, Beijing, China
Xinyang Central Hospital
Ningbo No. 1 Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Guangxi Medical University
Shenzhen Sun Yat-sen Cardiovascular Hospital
Guangdong Provincial People's Hospital
Zhongshan Hospital Xiamen University
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Atrial Tachycardia * Atrial Premature Complexes
Exclusion criteria
* Left Atrial Premature Complexes * Left Atrial Tachycardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total success rates | 3 months | The patients have no related arrhythias or recurrence during follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 6 months | The patients have no related complications during follow up. |
| Immediate success rate | 24 hours | Electrophysiologic study shows success of ablation |
| Total procedure time | during procedure | The patients have no related arrhythias or recurrence during follow up. |
| Fluoroscopy time | during procedure | From skin puncture to withdrawal of all the catheters. |
| Recurrence rate | 6 months | The patients have no related arrhythias or recurrence during follow up. |
Countries
China
Outcome results
None listed