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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
Sponsor:
Collaborators:
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 General Hospital
Zhongshan Hospital Xiamen University
Information provided by (Responsible Party):
Yan Wang, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Arrhythmia Atrial Premature Complexes Atrial Tachycardia Procedure: Zero-fluoroscopy ablation Procedure: Conventional fluoroscopy ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Total success rates [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: during procedure ]
  2. Fluoroscopy time [ Time Frame: during procedure ]
  3. Complications [ Time Frame: 6 months ]
  4. Immediate success rate [ Time Frame: 24 hours ]
  5. Recurrence rate [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial Tachycardia
  • Atrial Premature Complexes

Exclusion Criteria:

  • Left Atrial Premature Complexes
  • Left Atrial Tachycardia

Information from the National Library of Medicine

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


Contacts
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Contact: Yan Wang, PhD 86-27-83663280 newswangyan@tjh.tjmu.edu.cn
Contact: Guangzhi Chen, PhD 86-27-83662842 chengz2003@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Yan Wang, PhD    +86-13697326307    newswangyan@126.com   
Contact: Guangzhi Chen, PhD    86-27-83662842    chengz2003@163.com   
Sponsors and Collaborators
Tongji Hospital
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 General Hospital
Zhongshan Hospital Xiamen University
Investigators
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Principal Investigator: Yan Wang, PhD Tongji Hospital

Publications:

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Responsible Party: Yan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03151278     History of Changes
Other Study ID Numbers: TJHCDD-ZF-RAA-20110131
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Wang, Tongji Hospital:
Fluoroscopy
Ablation
Three dimensional
Atrial arrhythmia
Radiation
Additional relevant MeSH terms:
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Tachycardia
Atrial Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Cardiac Complexes, Premature