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

May 11, 2017 updated by: Yan Wang, Tongji Hospital

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

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.

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 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.

Study Type

Interventional

Enrollment (Anticipated)

450

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 Contact

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:

  • Atrial Tachycardia
  • Atrial Premature Complexes

Exclusion Criteria:

  • Left Atrial Premature Complexes
  • Left Atrial 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zero-fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under the guidance of Ensite NavX without fluoroscopy.
Procedure: Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
ACTIVE_COMPARATOR: Conventional fluoroscopy ablation
Atrial arrhythmias will be mapped and ablated under the guidance of X-ray plus any tree dimensional mapping system.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total 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: 6 months
6 months
Immediate success rate
Time Frame: 24 hours
24 hours
Recurrence rate
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Tongji Hospital

Collaborators

Zhongshan Hospital Xiamen University
Guangdong Provincial People's Hospital
Fu Wai Hospital, Beijing, China
Ningbo No. 1 Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Guangxi Medical University
Xinyang Central Hospital
Shenzhen Sun Yat-sen Cardiovascular 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

January 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHCDD-ZF-RAA-20110131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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