Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

Atrial Arrhythmia Clinical Trial

— ZFA-RAA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151278
• Other study ID #: TJHCDD-ZF-RAA-20110131
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2018

Study information

• Verified date: November 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Atrial Tachycardia
• Atrial Premature Complexes

Exclusion Criteria:

• Left Atrial Premature Complexes
• Left Atrial Tachycardia

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Premature Complexes
• Atrial Tachycardia
• Tachycardia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (9)

Lead Sponsor	Collaborator
Tongji Hospital	First Affiliated Hospital of Guangxi Medical University, Fu Wai Hospital, Beijing, China, Guangdong Provincial People's Hospital, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shenzhen Sun Yat-sen Cardiovascular Hospital, Xinyang Central Hospital, Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total success rates	The patients have no related arrhythias or recurrence during follow up.	3 months
Secondary	Total procedure time	The patients have no related arrhythias or recurrence during follow up.	during procedure
Secondary	Fluoroscopy time	From skin puncture to withdrawal of all the catheters.	during procedure
Secondary	Complications	The patients have no related complications during follow up.	6 months
Secondary	Immediate success rate	Electrophysiologic study shows success of ablation	24 hours
Secondary	Recurrence rate	The patients have no related arrhythias or recurrence during follow up.	6 months