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

Atrial Fibrillation Clinical Trial

— ISOCHRONE-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564951
• Other study ID #: NIMAO/2017-02/MG-01
• Status: Completed
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: August 19, 2020

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Atrial fibrillation ablation
ablation of Atrial fibrillation using spatio-temporal dispersion
• Atrial fibrillation ablation
ablation of concordance zones using isochrone and voltage maps

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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