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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country175 target enrollmentFebruary 14, 2019

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 175
Locations: 2
Primary Endpoint: Atrial fibrillation relapse in non-reducible or non-inducible patients
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 14, 2019

End Date

September 10, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Atrial fibrillation relapse in non-reducible or non-inducible patients

Time Frame: Month 18

Atrial fibrillation detected by routine or event-associated Holter examination

Secondary Outcomes

Atrial fibrillation relapse in non-reducible or non-inducible patients(Month 12)
Arrhythmia occurrence in non-reducible or non-inducible patients(Month 18)
Identification of zones of low voltage on voltage maps in non-inducible patients(Day 0)
Identification of zones of anisochronic zones on voltage maps in non-inducible patients(Day 0)
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)
Total time of radiofrequency in non-inducible patients(Day 0)
Total procedure time in non-inducible patients(Day 0)
Comparison of lesion volume in non-inducible patients(Day 0)
Number and size of treated zones by guided versus conventional ablation in non-inducible patients(Day 0)
List locations most frequently treated(Day 0)
Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients(Month 18)