NCT02681926

Brief Summary

Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A novel technology was recently developed to allow an automatic points annotation when indirect parameters of lesion formation reach predefined target values. The aim of the study was to evaluate, in a prospective and multicenter study, the safety, efficiency and PVI effectiveness of a new ablation tracking tool (VISITAG; Biosense Webster) during paroxysmal AF ablation using a contact force sensing catheter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 15, 2025

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

February 3, 2016

Last Update Submit

December 8, 2025

Conditions

Catheter Ablation, RadiofrequencyAtrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Freedom from atrial fibrillation or other sustained atrial arrhythmias during 12 month after ablation, excluding 3 month of blanking period.

    To determine the effectiveness at 12 month of a new ablation tracking tool called VISITAG (Biosense Webster) .

    up to 12 months after ablation

  • Freedom from major and minor complications during 1 month after ablation (SAFETY OUTCOME)

    To determine the safety at 1 month of a new ablation tracking tool called VISITAG (Biosense Webster)

    up to 1 month after ablation

Secondary Outcomes (3)

  • Comparison of incidence of complications during 1 month after ablation using different VISITAG settings.

    up to 1 month after ablation

  • Freedom from atrial arrhythmias during 12 months after ablation (excluding 3 month blanking period) using different VISITAG settings.

    up to12 months after ablation

  • Radiofrequency duration and procedural duration using different VISITAG settings.

    procedure

Study Arms (2)

Average force group

A recent tool, called VISITAG, has been developed (and approved by EMEA) for Biosense Webster Navistar Smart Touch catheter in order to allow collection of ablation points with pre-determined characteristics, such as stability of catheter during ablation, mean contact force, drop in impedance. In the Average Force group, the operators decided to use the mean contact force as target parameter indicating a good lesion.

Procedure: VISITAG

Force Time Integral group

In the Force Time Integral (FTI) group, the operators decided to use the FTI as target parameter indicating a good lesion.

Procedure: VISITAG

Interventions

VISITAGPROCEDURE

Paroxysmal atrial Fibrillation (PAF) ablation with contact force technology

Average force groupForce Time Integral group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients undergoing PAF ablation with abovementioned devices in several centers in Italy

You may qualify if:

  • PAF undergoing first ablation
  • Patient was above the minimum age as required by local regulations to be participating in a registry regardless of gender and race;
  • Provided Signed Informed Consent for the procedure.

You may not qualify if:

  • Patient had not to be included if any of the following conditions existed:
  • Persistent or permanent atrial fibrillation;
  • Redo ablation
  • Age\>75
  • Left atrium diameter (LAD) \> 50 mm
  • Participation in another drug or device study that would have jeopardized the appropriate analysis of end-points of this study.
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUPisana

Pisa, Italy, 56100, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 15, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 15, 2025

Record last verified: 2016-02

Locations

IT(1)