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

February 2, 2017 updated by: Yan Wang, Tongji Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Atrioventricular Nodal Reentrant Tachycardia
  • Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

  • Atrial Tachycardia
  • Organic supraventricular tachycardia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procedural success rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: one year
one year
Immediate success rate
Time Frame: one day
one day
Recurrence Rate
Time Frame: 1 year
1 year
Total procedure time
Time Frame: one day
one day
Fluoroscopy time
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Ningbo No. 1 Hospital
First Affiliated Hospital of Guangxi Medical University
Xiangyang Central Hospital
Morristown Memorial Hospital

Investigators

  • Principal Investigator: Yan Wang, PhD, Tongji Hospital Wuhan, Hubei China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (ESTIMATE)

February 3, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHCDD-ZF-PSVT-20140301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe