NCT05109273

Brief Summary

The WATER ATTAC study aims at multicentric, longitudinal, perspective evaluation of safety and efficacy of atrioventricular nodal reentrant tachycardia (AVNRT) performed combining irrigated ablation catheter and three-dimensional electroanatomic mapping system. Efficacy and rate of complications will be evaluated over medium and long term follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

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

First Submitted

Initial submission to the registry

October 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

October 26, 2021

Last Update Submit

May 29, 2026

Conditions

Keywords

AVNRTAblationElectroanatomical mapping systemIrrigated catheterRadiofrequencyArrhythmiasElectrophysiologySVTSlow-Fast

Outcome Measures

Primary Outcomes (2)

  • Procedural success

    Recurrence of AVNRT during follow-up

    12 months

  • Procedural complication

    AV iatrogenic block

    12 months

Secondary Outcomes (1)

  • Acute success rate

    Immediate post-procedure

Interventions

Three-dimensional electroanatomic mapping and radiofrequency ablation with irrigated catheter

Eligibility Criteria

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

Patients undergoing EPS for SVT, with confirm of AVNRT at EPS, treated with transcatheter ablation by means of irrigated catheter and 3D electroanatomic mapping system

You may qualify if:

  • Patients undergoing electrophysiologic study (EPS) for paroxysmal supraventricular tachycardia
  • evidence of dual AV node pathway or atrioventricular nodal reentrant tachycardia (AVNRT) induction at EPS
  • Attempt of AVNRT ablation with irrigated catheter and three-dimensionale electroanatomic mapping system

You may not qualify if:

  • Age \<18 years
  • Ablation with non-irrigated catheter
  • Ablation without electroanatomic mapping system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy, 44124, Italy

Location

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal ReentryArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingTachycardiaHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matteo Bertini, MD, PhD

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

December 1, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations