Clinical trial NCT03041519: Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Arrythmia
Ventricular Premature Complexes
Ventricular Tachycardia
Keywords: Fluoroscopy
Ablation
Three dimensional
Ventricular arrhythmias
Radiation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Xinyang Central Hospital
name: Ningbo No. 1 Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Guangxi Medical University
First posted: 2017-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Ventricular Tachycardia
* Ventricular Premature Complexes

Exclusion Criteria:

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

Primary outcomes:
measure: Procedural success rates
timeFrame: 3 months
Secondary outcomes:
measure: Total procedure time
timeFrame: during procedure
measure: Fluoroscopy time
timeFrame: during procedure
measure: Complications
timeFrame: 1 year
measure: Immediate success rate
timeFrame: 10~30minutes
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Yan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24.
citation: Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.
citation: Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.