Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation (ISOCHRONE-AF)

Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Atrial fibrillation ablation; Procedure: Atrial fibrillation ablation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nîmes, France, 30029
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 has paroxysmal or persistent atrial fibrillation
• The patient is available for 18 month follow-up

Exclusion Criteria:

• The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
• 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
• The patient is pregnant or breastfeeding
• Sinus rhythm has not been able to be determined using external electric cardioversion
• Patient not susceptible to atrial fibrillation following wide antrum circle ablation
• The subject has already been included in the study (patients cannot be included more than once)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; ablation of Atrial fibrillation using spatio-temporal dispersion	Procedure: Atrial fibrillation ablation; ablation of Atrial fibrillation using spatio-temporal dispersion; Procedure: Atrial fibrillation ablation; ablation of concordance zones using isochrone and voltage maps
EXPERIMENTAL: Isochrone; ablation of concordance zones using isochrone and voltage maps	Procedure: Atrial fibrillation ablation; ablation of Atrial fibrillation using spatio-temporal dispersion; Procedure: Atrial fibrillation ablation; ablation of concordance zones using isochrone and voltage maps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation relapse between groups	Atrial fibrillation detected by routine or event-associated Holter examination	Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
List locations most frequently treated	Number of each	Day 0
Atrial fibrillation relapse between groups	Atrial fibrillation detected by routine or event-associated Holter examination	Month 12
Arrhythmia occurrence between groups	Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination	Month 12
Arrhythmia occurrence between groups	Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination	Month 18
Concordance of isochrone and voltage maps	Binary yes/no	Day 0
Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region		Day 0
Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region		Day 0
Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region	degrees	Day 0
Total time of radiofrequency between groups	Minutes	Day 0
Comparison of lesion volume between groups	Force-time integral, lesion size index or stroke volume index	Day 0
Total procedure time between groups	Minutes	Day 0
Number of treated zones between groups		Day 0
Size of treated zones between groups	cm2	Day 0
Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.	Atrial fibrillation detected by routine or event-associated Holter examination	Month 18
Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.	Atrial fibrillation detected by routine or event-associated Holter examination	Month 18

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2019
• Primary Completion (ACTUAL): August 19, 2020
• Study Completion (ACTUAL): August 19, 2020

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NIMAO/2017-02/MG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No