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Trial record 17 of 5959 for:    zero

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

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ClinicalTrials.gov Identifier: NCT03042078
Recruitment Status : Unknown
Verified February 2017 by Yan Wang, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : February 6, 2017
Sponsor:
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 General Hospital
Morristown Memorial Hospital
Beijing Anzhen Hospital
Ningbo No. 1 Hospital
Information provided by (Responsible Party):
Yan Wang, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Paroxysmal Supraventricular Tachycardia Device: Zero-fluoroscopic ablation Device: Conventional fluoroscopic ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Zero-fluoroscopic ablation
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.
Device: Zero-fluoroscopic ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.

Active Comparator: Conventional fluoroscopic ablation
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.
Device: Conventional fluoroscopic ablation
Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.




Primary Outcome Measures :
  1. Procedural success rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: one year ]
  2. Immediate success rate [ Time Frame: one day ]
  3. Recurrence Rate [ Time Frame: 1 year ]
  4. Total procedure time [ Time Frame: one day ]
  5. Fluoroscopy time [ Time Frame: one day ]


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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrioventricular Nodal Reentrant Tachycardia
  • Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

  • Atrial Tachycardia
  • Organic supraventricular 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): NCT03042078


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
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 General Hospital
Morristown Memorial Hospital
Beijing Anzhen Hospital
Ningbo No. 1 Hospital
Investigators
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Principal Investigator: Yan Wang, PhD Tongji Hospital Wuhan, Hubei China

Publications:
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Responsible Party: Yan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03042078     History of Changes
Other Study ID Numbers: TJHCDD-ZF-PSVT-20140301
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yan Wang, Tongji Hospital:
Fluoroscopy
Ablation
Three dimensional
Paroxysmal supraventricular tachycardia
Radiation

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes