Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Wide antrum circle ablation; Procedure: External electric cardioversion

• Registration Number: NCT03564327
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-20
• Study Start: 2019-02-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-13
• Primary Completion: 2022-09
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

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 Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with sinus rhythm	Wide antrum circle ablation	-
patients with atrial fibrillation	External electric cardioversion	-

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation relapse in non-reducible or non-inducible patients	Month 18	Atrial fibrillation detected by routine or event-associated Holter examination

Secondary Outcome Measures

Name	Time	Method
Arrhythmia occurrence in non-reducible or non-inducible patients	Month 18	Atrial fibrillation detected by routine or event-associated Holter examination
Identification of zones of anisochronic zones on voltage maps in non-inducible patients	Day 0	Yes/No
Maximum variation of conduction speed in the same anatomic region in non-inducible patients	Day 0
Wave front rotation in the same anatomic region in non-inducible patients	Day 0	degrees
Total procedure time in non-inducible patients	Day 0	Minutes
Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients	Month 18	Atrial fibrillation detected by routine or event-associated Holter examination
Comparison of lesion volume in non-inducible patients	Day 0	Force-time integral, lesion size index or stroke volume index
Identification of zones of low voltage on voltage maps in non-inducible patients	Day 0	Yes/No
Decreasing velocities in the same anatomic region in non-inducible patients	Day 0
Atrial fibrillation relapse in non-reducible or non-inducible patients	Month 12	Atrial fibrillation detected by routine or event-associated Holter examination
Total time of radiofrequency in non-inducible patients	Day 0	Minutes
Number and size of treated zones by guided versus conventional ablation in non-inducible patients	Day 0	cm2
List locations most frequently treated	Day 0	Number of each

Trial Locations

Locations (2)

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France