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

NCT03564951 | Completed

• 1 other identifier: NIMAO/2017-02/MG-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation relapse between groups

  Atrial fibrillation detected by routine or event-associated Holter examination

  Month 18

Secondary Outcomes (15)

• Atrial fibrillation relapse between groups

  Month 12

• Arrhythmia occurrence between groups

  Month 12

• Arrhythmia occurrence between groups

  Month 18

• Concordance of isochrone and voltage maps

  Day 0

• Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region

  Day 0

Study Arms (2)

Control

ACTIVE COMPARATOR

ablation of Atrial fibrillation using spatio-temporal dispersion

Procedure: Atrial fibrillation ablation

Isochrone

EXPERIMENTAL

ablation of concordance zones using isochrone and voltage maps

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

ablation of Atrial fibrillation using spatio-temporal dispersion

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 has paroxysmal or persistent atrial fibrillation
• The patient is available for 18 month follow-up

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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: February 14, 2019
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-03

Locations

FR (2)