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Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03564327
Acronym
Isochrone-AFAn
Enrollment
175
Registered
2018-06-20
Start date
2019-02-14
Completion date
2024-09-10
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

Three attempts (200-250 joules)

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillation relapse in non-reducible or non-inducible patientsMonth 18Atrial fibrillation detected by routine or event-associated Holter examination

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026