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NCT Number: NCT03042078

Zero-fluoroscopy Approach Versus 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.

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Key information

Conditions

Paroxysmal Supraventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

12 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Atrioventricular Nodal Reentrant Tachycardia
  • Atrioventricular Reentrant Tachycardia

Exclusion criteria

  • Atrial Tachycardia
  • Organic supraventricular tachycardia

Treatment and study plan

Zero-fluoroscopic ablation

Device

Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.

Conventional fluoroscopic ablation

Device

Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.

Primary outcomes

  1. Procedural success rate

    Time frame: one year

    Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.

Secondary outcomes

  1. Complications

    Time frame: one year

    Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention.

  2. Immediate success rate

    Time frame: one day

    Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.

  3. Recurrence Rate

    Time frame: 1 year

    • An ECG and electrophysiology study would be performed to rule out recurrence when the patients had suspicious symptoms or signs.

  4. Total procedure time

    Time frame: one day

    Procedure time (in minutes) was defined as the interval from the beginning of local anesthesia to extraction of all femoral venous sheaths at the end of the procedure. Total ablation time was calculated in seconds but time for tentative ablation was not taken into account.

  5. Fluoroscopy time

    Time frame: one day

    • Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Official study 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

Acronym: ZFA-PSVT

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Feb 3, 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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