Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

NCT ID: NCT03042078

Last Updated: 2023-11-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

3060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Paroxysmal Supraventricular Tachycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Zero-fluoroscopic ablation

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.

Group Type EXPERIMENTAL

Zero-fluoroscopic ablation

Intervention Type DEVICE

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

Conventional fluoroscopic ablation

Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.

Group Type ACTIVE_COMPARATOR

Conventional fluoroscopic ablation

Intervention Type DEVICE

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

Interventions

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Zero-fluoroscopic ablation

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

Intervention Type DEVICE

Conventional fluoroscopic ablation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Atrioventricular Nodal Reentrant Tachycardia
* Atrioventricular Reentrant Tachycardia

Exclusion Criteria

* Atrial Tachycardia
* Organic supraventricular tachycardia
Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Morristown Memorial Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

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 Wuhan, Hubei China

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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)

Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.

Reference Type BACKGROUND
PMID: 26034742 (View on PubMed)

Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.

Reference Type BACKGROUND
PMID: 23750689 (View on PubMed)

Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.

Reference Type BACKGROUND
PMID: 22875320 (View on PubMed)

Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16.

Reference Type BACKGROUND
PMID: 20843630 (View on PubMed)

Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0.

Reference Type DERIVED
PMID: 32013865 (View on PubMed)

Other Identifiers

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TJHCDD-ZF-PSVT-20140301

Identifier Type: -

Identifier Source: org_study_id