Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

Atrial Fibrillation Clinical Trial

— Isochrone-AFAn  

Official title:

Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564327
• Other study ID #: NIMAO/2017-03/MG-02
• Status: Recruiting
• Start date: February 14, 2019
• Est. completion date: March 2024

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Mathieu Granier, MD
• Phone: 04.67.33.67.33
• Email: m-granier[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 2024
• Est. primary completion date: September 2022
• 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 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Wide antrum circle ablation
As standard hospital policy
• External electric cardioversion
Three attempts (200-250 joules)

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