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Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia (ZFA-PSVT)

Primary Purpose

Paroxysmal Supraventricular Tachycardia

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

About this trial

This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia focused on measuring Fluoroscopy, Ablation, Three dimensional, Paroxysmal supraventricular tachycardia, Radiation

Eligibility Criteria

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

Inclusion Criteria:

  • Atrioventricular Nodal Reentrant Tachycardia
  • Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

  • Atrial Tachycardia
  • Organic supraventricular tachycardia

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero-fluoroscopic ablation

Conventional fluoroscopic ablation

Arm Description

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.

Outcomes

Primary Outcome Measures

Procedural success rate

Secondary Outcome Measures

Complications
Immediate success rate
Recurrence Rate
Total procedure time
Fluoroscopy time

Full Information

First Posted
January 27, 2017
Last Updated
February 2, 2017
Sponsor
Tongji Hospital
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xiangyang Central Hospital, First Affiliated Hospital of Guangxi Medical University, Guangdong Provincial People's Hospital, Morristown Memorial Hospital, Beijing Anzhen Hospital, Ningbo No. 1 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03042078
Brief Title
Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
Acronym
ZFA-PSVT
Official Title
Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (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
Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xiangyang Central Hospital, First Affiliated Hospital of Guangxi Medical University, Guangdong Provincial People's Hospital, Morristown Memorial Hospital, Beijing Anzhen Hospital, Ningbo No. 1 Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Detailed Description
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Supraventricular Tachycardia
Keywords
Fluoroscopy, Ablation, Three dimensional, Paroxysmal supraventricular tachycardia, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zero-fluoroscopic ablation
Arm Type
Experimental
Arm Description
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.
Arm Title
Conventional fluoroscopic ablation
Arm Type
Active Comparator
Arm Description
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.
Intervention Type
Device
Intervention Name(s)
Zero-fluoroscopic ablation
Intervention Description
Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
Intervention Type
Device
Intervention Name(s)
Conventional fluoroscopic ablation
Intervention Description
Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
Primary Outcome Measure Information:
Title
Procedural success rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
Complications
Time Frame
one year
Title
Immediate success rate
Time Frame
one day
Title
Recurrence Rate
Time Frame
1 year
Title
Total procedure time
Time Frame
one day
Title
Fluoroscopy time
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atrioventricular Nodal Reentrant Tachycardia Atrioventricular Reentrant Tachycardia Exclusion Criteria: Atrial Tachycardia Organic supraventricular 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 Wuhan, Hubei China
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
22526222
Citation
Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.
Results Reference
background
PubMed Identifier
26034742
Citation
Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.
Results Reference
background
PubMed Identifier
23750689
Citation
Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.
Results Reference
background
PubMed Identifier
22875320
Citation
Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.
Results Reference
background
PubMed Identifier
20843630
Citation
Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16. Erratum In: J Vasc Surg. 2012 Feb;55(2):627.
Results Reference
background
PubMed Identifier
32013865
Citation
Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0.
Results Reference
derived

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Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

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