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Atrial FibrillationISOCHRONE-AFNCT03564951

Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

A study testing Atrial fibrillation ablation in people with Atrial Fibrillation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Atrial fibrillation ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesFrance
Study dates
14 Feb 2019to 19 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 has paroxysmal or persistent atrial fibrillation
  • The patient is available for 18 month follow-up

Who cannot join

  • 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
  • Sinus rhythm has not been able to be determined using external electric cardioversion
  • Patient not susceptible to atrial fibrillation following wide antrum circle ablation
  • The subject has already been included in the study (patients cannot be included more than once)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

Official title: Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.

Being tested
Atrial fibrillation ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atrial fibrillation ablationProcedure or surgery

    ablation of Atrial fibrillation using spatio-temporal dispersion

  • Atrial fibrillation ablationProcedure or surgery

    ablation of concordance zones using isochrone and voltage maps

Study groups in NCT03564951
Study groupRoleWhat they receive
ControlActive comparatorablation of Atrial fibrillation using spatio-temporal dispersion
Receives: Procedure: Atrial fibrillation ablation
IsochroneExperimentalablation of concordance zones using isochrone and voltage maps
Receives: Procedure: Atrial fibrillation ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial fibrillation relapse between groups

    Atrial fibrillation detected by routine or event-associated Holter examination

    Measured: Month 18

Secondary outcomes (15)

  1. Atrial fibrillation relapse between groups

    Atrial fibrillation detected by routine or event-associated Holter examination

    Measured: Month 12

  2. Arrhythmia occurrence between groups

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

    Measured: Month 12

  3. Arrhythmia occurrence between groups

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

    Measured: Month 18

  4. Concordance of isochrone and voltage maps

    Binary yes/no

    Measured: Day 0

  5. Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region

    Measured: Day 0

  6. Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region

    Measured: Day 0

  7. Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region

    degrees

    Measured: Day 0

  8. Total time of radiofrequency between groups

    Minutes

    Measured: Day 0

  9. Comparison of lesion volume between groups

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

    Measured: Day 0

  10. Total procedure time between groups

    Minutes

    Measured: Day 0

  11. Number of treated zones between groups

    Measured: Day 0

  12. Size of treated zones between groups

    cm2

    Measured: Day 0

  13. List locations most frequently treated

    Number of each

    Measured: Day 0

  14. Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.

    Atrial fibrillation detected by routine or event-associated Holter examination

    Measured: Month 18

  15. Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.

    Atrial fibrillation detected by routine or event-associated Holter examination

    Measured: Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start14 Feb 2019
  3. Primary completion19 Aug 2020
  4. Study completion19 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564951
Sponsor's protocol ID
NIMAO/2017-02/MG-01
Acronym
ISOCHRONE-AF
Status last verified
Mar 2020
First submitted
11 Jun 2018
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Atrial fibrillation ablation in people with Atrial Fibrillation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation relapse between groups (time frame: Month 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03564951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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