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Completed

NCT Number: NCT03151278

Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for 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.

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Key information

Conditions

Atrial Arrhythmia Arrhythmias, Cardiac Atrial Premature Complexes Atrial Tachycardia Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atrial Tachycardia
  • Atrial Premature Complexes

Exclusion criteria

  • Left Atrial Premature Complexes
  • Left Atrial Tachycardia

Treatment and study plan

Zero-fluoroscopy ablation

Procedure

Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.

Conventional fluoroscopy ablation

Procedure

Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.

Primary outcomes

  1. Total success rates

    Time frame: 3 months

    The patients have no related arrhythias or recurrence during follow up.

Secondary outcomes

  1. Total procedure time

    Time frame: during procedure

    The patients have no related arrhythias or recurrence during follow up.

  2. Fluoroscopy time

    Time frame: during procedure

    From skin puncture to withdrawal of all the catheters.

  3. Complications

    Time frame: 6 months

    The patients have no related complications during follow up.

  4. Immediate success rate

    Time frame: 24 hours

    Electrophysiologic study shows success of ablation

  5. Recurrence rate

    Time frame: 6 months

    The patients have no related arrhythias or recurrence during follow up.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ZFA-RAA

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
May 12, 2017
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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