NCT03041519

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

January 29, 2017

Last Update Submit

January 31, 2017

Conditions

Ventricular ArrythmiaVentricular Premature ComplexesVentricular Tachycardia

Keywords

FluoroscopyAblationThree dimensionalVentricular arrhythmiasRadiation

Outcome Measures

Primary Outcomes (1)

  • Procedural success rates

    3 months

Secondary Outcomes (4)

  • Total procedure time

    during procedure

  • Fluoroscopy time

    during procedure

  • Complications

    1 year

  • Immediate success rate

    10~30minutes

Study Arms (2)

Zero-fluoroscopy ablation

EXPERIMENTAL

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.

Procedure: Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

ACTIVE COMPARATOR

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

Procedure: Conventional fluoroscopy ablation

Interventions

Zero-fluoroscopy ablationPROCEDURE

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

Zero-fluoroscopy ablation
Conventional fluoroscopy ablationPROCEDURE

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

Conventional fluoroscopy ablation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25432138BACKGROUND

  • 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

  • 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.

    PMID: 24273563BACKGROUND

MeSH Terms

Conditions

Ventricular Premature ComplexesTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia

Study Officials

  • Yan Wang, PhD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, PhD

CONTACT

86-27-83663280newswangyan@tjh.tjmu.edu.cn

Guangzhi Chen, PhD

CONTACT

86-27-83662842chengz2003@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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 29, 2017

First Posted

February 2, 2017

Study Start

October 1, 2011

Primary Completion

July 1, 2017

Study Completion

December 1, 2018

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)