NCT03042078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

6.1 years

First QC Date

January 27, 2017

Last Update Submit

November 20, 2023

Conditions

Paroxysmal Supraventricular Tachycardia

Keywords

FluoroscopyAblationThree dimensionalParoxysmal supraventricular tachycardiaRadiation

Outcome Measures

Primary Outcomes (1)

  • Procedural success rate

    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.

    one year

Secondary Outcomes (5)

  • Complications

    one year

  • Immediate success rate

    one day

  • Recurrence Rate

    1 year

  • Total procedure time

    one day

  • Fluoroscopy time

    one day

Study Arms (2)

Zero-fluoroscopic ablation

EXPERIMENTAL

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

Device: Zero-fluoroscopic ablation

Conventional fluoroscopic ablation

ACTIVE COMPARATOR

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

Device: Conventional fluoroscopic ablation

Interventions

Zero-fluoroscopic ablationDEVICE

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

Zero-fluoroscopic ablation
Conventional fluoroscopic ablationDEVICE

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

Conventional fluoroscopic ablation

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Atrioventricular Nodal Reentrant Tachycardia
  • Atrioventricular Reentrant Tachycardia

You may not qualify if:

  • Atrial Tachycardia
  • Organic supraventricular tachycardia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (6)

  • 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.

    PMID: 22526222BACKGROUND

  • 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.

    PMID: 26034742BACKGROUND

  • 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.

    PMID: 23750689BACKGROUND

  • 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.

    PMID: 22875320BACKGROUND

  • 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.

    PMID: 20843630BACKGROUND

  • 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.

    PMID: 32013865DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yan Wang, PhD

    Tongji Hospital Wuhan, Hubei China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 3, 2017

Study Start

January 1, 2012

Primary Completion

February 1, 2018

Study Completion

December 1, 2018

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)