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Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias (ZFA-RAA)

Primary Purpose

Atrial Arrhythmia, Atrial Premature Complexes, Atrial Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zero-fluoroscopy ablation
Conventional fluoroscopy ablation
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Arrhythmia focused on measuring Fluoroscopy, Ablation, Three dimensional, Atrial arrhythmia, Radiation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Atrial Tachycardia
  • Atrial Premature Complexes

Exclusion Criteria:

  • Left Atrial Premature Complexes
  • Left Atrial Tachycardia

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

Arm Description

Atrial arrhythmias will be mapped and ablated under the guidance of Ensite NavX without fluoroscopy.

Atrial arrhythmias will be mapped and ablated under the guidance of X-ray plus any tree dimensional mapping system.

Outcomes

Primary Outcome Measures

Total success rates

Secondary Outcome Measures

Total procedure time
Fluoroscopy time
Complications
Immediate success rate
Recurrence rate

Full Information

First Posted
May 11, 2017
Last Updated
May 11, 2017
Sponsor
Tongji Hospital
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 Provincial People's Hospital, Zhongshan Hospital Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT03151278
Brief Title
Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
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 Provincial People's Hospital, Zhongshan Hospital Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Arrhythmia, Atrial Premature Complexes, Atrial Tachycardia
Keywords
Fluoroscopy, Ablation, Three dimensional, Atrial arrhythmia, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zero-fluoroscopy ablation
Arm Type
Experimental
Arm Description
Atrial arrhythmias will be mapped and ablated under the guidance of Ensite NavX without fluoroscopy.
Arm Title
Conventional fluoroscopy ablation
Arm Type
Active Comparator
Arm Description
Atrial arrhythmias will be mapped and ablated under the guidance of X-ray plus any tree dimensional mapping system.
Intervention Type
Procedure
Intervention Name(s)
Zero-fluoroscopy ablation
Intervention Description
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
Intervention Type
Procedure
Intervention Name(s)
Conventional fluoroscopy ablation
Intervention Description
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Primary Outcome Measure Information:
Title
Total success rates
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Total procedure time
Time Frame
during procedure
Title
Fluoroscopy time
Time Frame
during procedure
Title
Complications
Time Frame
6 months
Title
Immediate success rate
Time Frame
24 hours
Title
Recurrence rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atrial Tachycardia Atrial Premature Complexes Exclusion Criteria: Left Atrial Premature Complexes Left Atrial Tachycardia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, PhD
Phone
86-27-83663280
Email
newswangyan@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guangzhi Chen, PhD
Phone
86-27-83662842
Email
chengz2003@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Phone
+86-13697326307
Email
newswangyan@126.com
First Name & Middle Initial & Last Name & Degree
Guangzhi Chen, PhD
Phone
86-27-83662842
Email
chengz2003@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22233800
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.
Results Reference
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PubMed Identifier
21385267
Citation
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.
Results Reference
background
PubMed Identifier
15851266
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.
Results Reference
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PubMed Identifier
18266669
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.
Results Reference
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PubMed Identifier
22571735
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.
Results Reference
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Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

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