NCT03564327

Brief Summary

Identify the parameters of the predictive isochronous map for the clinical outcome of radiofrequency ablation in terms of absence of documented atrial fibrillation recurrence at 18 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

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

June 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

December 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

June 11, 2018

Last Update Submit

December 16, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation relapse in non-reducible or non-inducible patients

    Atrial fibrillation detected by routine or event-associated Holter examination

    Month 18

Secondary Outcomes (15)

  • Atrial fibrillation relapse in non-reducible or non-inducible patients

    Month 12

  • Arrhythmia occurrence in non-reducible or non-inducible patients

    Month 12

  • Arrhythmia occurrence in non-reducible or non-inducible patients

    Month 18

  • Identification of zones of low voltage on voltage maps in non-inducible patients

    Day 0

  • Identification of zones of anisochronic zones on voltage maps in non-inducible patients

    Day 0

  • +10 more secondary outcomes

Study Arms (1)

patients with atrial fibrillation

EXPERIMENTAL
Procedure: External electric cardioversion

Interventions

External electric cardioversionPROCEDURE

Three attempts (200-250 joules)

patients with atrial fibrillation

Eligibility Criteria

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

You may qualify if:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient is available for 18 month follow-up
  • The patient has paroxysmal or persistent atrial fibrillation

You may not qualify if:

  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mathieu Granier, MD

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 20, 2018

Study Start

February 14, 2019

Primary Completion

February 9, 2023

Study Completion

September 10, 2024

Last Updated

December 22, 2025

Record last verified: 2025-09

Locations

FR(2)