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| Name | Class |
|---|---|
| Fu Wai Hospital, Beijing, China | OTHER |
| Xinyang Central Hospital | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero-fluoroscopy ablation | Experimental | Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy. |
|
| Conventional fluoroscopy ablation | Active Comparator | Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero-fluoroscopy ablation | Procedure | Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total success rates | The patients have no related arrhythias or recurrence during follow up. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | The patients have no related arrhythias or recurrence during follow up. | during procedure |
| Fluoroscopy time | From skin puncture to withdrawal of all the catheters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233800 | Background | 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. | |
| 21385267 | Background |
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| ID | Term |
|---|---|
| D018880 | Atrial Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
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| Conventional fluoroscopy ablation | Procedure | Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system. |
|
| during procedure |
| Complications | The patients have no related complications during follow up. | 6 months |
| Immediate success rate | Electrophysiologic study shows success of ablation | 24 hours |
| Recurrence rate | The patients have no related arrhythias or recurrence during follow up. | 6 months |
| 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. |
| 15851266 | Background | 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. |
| 18266669 | Background | 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. |
| 22571735 | Background | 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. |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |