Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias (ZFOVA)

January 31, 2017 updated by: Yan Wang, Tongji Hospital

Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Study Type

Interventional

Enrollment (Anticipated)

300

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

Exclusion Criteria:

  • Organic ventricular tachycardia or ventricular premature complexes
  • Drug-induced ventricular tachycardia or ventricular premature complexes

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zero-fluoroscopy ablation
Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.
Procedure: Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
ACTIVE_COMPARATOR: Conventional fluoroscopy ablation
Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procedural success rates
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total procedure time
Time Frame: during procedure
during procedure
Fluoroscopy time
Time Frame: during procedure
during procedure
Complications
Time Frame: 1 year
1 year
Immediate success rate
Time Frame: 10~30minutes
10~30minutes

Collaborators and Investigators

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

Sponsor

Tongji Hospital

Collaborators

Guangxi Medical University
Fu Wai Hospital, Beijing, China
Ningbo No. 1 Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Xinyang Central Hospital

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

October 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (ESTIMATE)

February 2, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHXXG-ZF-VT-20161220

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.

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