Skip to content

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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03041519
Acronym
ZFOVA
Enrollment
300
Registered
2017-02-02
Start date
2011-10-31
Completion date
2018-12-31
Last updated
2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrythmia, Ventricular Premature Complexes, Ventricular Tachycardia

Keywords

Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation

Brief summary

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.

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.

Interventions

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Ventricular Tachycardia * Ventricular Premature Complexes

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Procedural success rates3 months

Secondary

MeasureTime frame
Total procedure timeduring procedure
Fluoroscopy timeduring procedure
Complications1 year
Immediate success rate10~30minutes

Countries

China

Contacts

Primary ContactYan Wang, PhD
newswangyan@tjh.tjmu.edu.cn86-27-83663280
Backup ContactGuangzhi Chen, PhD
chengz2003@163.com86-27-83662842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026