Skip to main content
OpenTrials
Completed

NCT Number: NCT03564327

Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External electric cardioversion

Procedure

Three attempts (200-250 joules)

Primary outcomes

  1. 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

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

    Time frame: Month 12

    Atrial fibrillation detected by routine or event-associated Holter examination

  2. Arrhythmia occurrence in non-reducible or non-inducible patients

    Time frame: Month 12

    Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination

  3. Arrhythmia occurrence in non-reducible or non-inducible patients

    Time frame: Month 18

    Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination

  4. Identification of zones of low voltage on voltage maps in non-inducible patients

    Time frame: Day 0

    Yes/No

  5. Identification of zones of anisochronic zones on voltage maps in non-inducible patients

    Time frame: Day 0

    Yes/No

  6. Maximum variation of conduction speed in the same anatomic region in non-inducible patients

    Time frame: Day 0

    %

  7. Decreasing velocities in the same anatomic region in non-inducible patients

    Time frame: Day 0

    %

  8. Wave front rotation in the same anatomic region in non-inducible patients

    Time frame: Day 0

    degrees

  9. Total time of radiofrequency in non-inducible patients

    Time frame: Day 0

    Minutes

  10. Total procedure time in non-inducible patients

    Time frame: Day 0

    Minutes

  11. Comparison of lesion volume in non-inducible patients

    Time frame: Day 0

    Force-time integral, lesion size index or stroke volume index

  12. Number and size of treated zones by guided versus conventional ablation in non-inducible patients

    Time frame: Day 0

    cm2

  13. List locations most frequently treated

    Time frame: Day 0

    Number of each

  14. Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients

    Time frame: Month 18

    Atrial fibrillation detected by routine or event-associated Holter examination

  15. Arrhythmia occurrence in non-reducible or non-inducible patients

    Time frame: Month 18

    Atrial fibrillation detected by routine or event-associated Holter examination

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: Isochrone-AFAn

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jun 20, 2018
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.