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

NCT ID: NCT03041519

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Ventricular Arrythmia Ventricular Premature Complexes Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Zero-fluoroscopy ablation

Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.

Group Type EXPERIMENTAL

Zero-fluoroscopy ablation

Intervention Type PROCEDURE

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

Conventional fluoroscopy ablation

Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.

Group Type ACTIVE_COMPARATOR

Conventional fluoroscopy ablation

Intervention Type PROCEDURE

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

Interventions

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Zero-fluoroscopy ablation

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

Intervention Type PROCEDURE

Conventional fluoroscopy ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ventricular Tachycardia
* Ventricular Premature Complexes

Exclusion Criteria

* Organic ventricular tachycardia or ventricular premature complexes
* Drug-induced ventricular tachycardia or ventricular premature complexes
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role collaborator

Xinyang Central Hospital

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yan Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Wang, PhD

Role: CONTACT

86-27-83663280

Guangzhi Chen, PhD

Role: CONTACT

86-27-83662842

Facility Contacts

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Yan Wang, PhD

Role: primary

+86-13697326307

Guangzhi Chen, PhD

Role: backup

86-27-83662842

References

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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.

Reference Type BACKGROUND
PMID: 25432138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22526222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24273563 (View on PubMed)

Other Identifiers

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TJHXXG-ZF-VT-20161220

Identifier Type: -

Identifier Source: org_study_id

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