Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

Completed

• Conditions: Atrial Fibrillation

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

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.

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
• Primary Completion: 2023-02-09
• Study Completion: 2024-09-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

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
Atrial fibrillation relapse in non-reducible or non-inducible patients	Month 12	Atrial fibrillation detected by routine or event-associated Holter examination
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 low voltage on voltage maps in non-inducible patients	Day 0	Yes/No
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	%
Decreasing velocities 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 time of radiofrequency in non-inducible patients	Day 0	Minutes
Total procedure time in non-inducible patients	Day 0	Minutes
Comparison of lesion volume in non-inducible patients	Day 0	Force-time integral, lesion size index or stroke volume index
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
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

Trial Locations

Locations (2)

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France