ClinicalTrials.gg
Active, not recruitingNCT04945746Updated Sep 19, 2024

Dispersion Stability

An interventional study of AF ablation in Atrial Fibrillation, sponsored by Hospital St. Joseph, Marseille, France. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 317 studies in Atrial Fibrillation with a site in France — 63 open to participants now, 87 under way, 5 of them phase 3. Atrial Fibrillation · France.

Planned enrollment
181st of 193
35 · median 250
Started
2021
with 28 others
No phase
117 of 317
32 open now
Primary completion
2023-10
later than 3 of 86 live
Registered
222nd of 317
by date

Among the 317 studies in Atrial Fibrillation with a site in France, this one is the 181st largest by planned enrollment of the 193 interventional ones that give a count, is one of 29 that started in 2021, is one of 117 with no phase, reaches primary completion later than 3 of the 86 other live ones, and was the 222nd registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

63 of the 317 studies in Atrial Fibrillation with a site in France are open now. Recruiting first, the newest first:

58 more — sign in →

All 63 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination.

Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.

03

Conditions studied

  • Atrial Fibrillation

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (, Holter, physician's letter):

    • AF duration of ≥ 3 months and ≤ 5 years or
    • 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
  2. Continuous anticoagulation with warfarin ( 2-3) or NOAC for > 4 weeks prior to ablation
  3. Patients must be able and willing to provide written to participate in the clinical trial
  4. Maximum of 50% of patients (13 patients) in persistent AF \< 12 months (>30% of long-standing persistent AF ≥ 12 months)
  5. Being affiliated to a social security scheme or beneficiary of such a scheme

Exclusion criteria

Exclusion Criteria:

  1. Paroxysmal and short-standing persistent AF \< 3 months
  2. Severe obesity ( > 45)
  3. LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
  4. to anticoagulation (heparin, warfarin or NOAC)
  5. Patients who are or may potentially be pregnant
  6. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  7. Myocardial infarction within the past 2 months (60 days)
  8. History of blood clotting or bleeding abnormalities
  9. Documented thromboembolic event (including ) within the past 12 months (365 days)
  10. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  11. Unstable angina within the past month
  12. Acute illness or active systemic infection or sepsis (including COVID 19)
  13. Enrollment in an study evaluating another device, biologic, or drug
  14. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  15. or other disease processes likely to limit survival to less than 12 monthsLife expectancy or other disease processes likely to limit survival to less than 12 months
  16. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
  17. Patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
  18. Person subject to a safeguard measure.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Software VX1 + Stability

    Utilization of the software VX1 + Stability

    Procedure: AF ablation

Interventions

  • ProcedureAF ablation

    AF ablation using the Volta Medical VX1 CE marked software and a new criteria to establish a priority of the dispersed zones according to the stability of the core algorithm's response (thanks to the new software module under study named "stability").

06

What researchers measure

Primary outcomes

  1. AF termination rate after ablation of the most stable regions (levels 3 and 2)

    sinus rhythm at the end of the procedure

    Time frame: at the end of the procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Oct 2023, 26 months.

Of 795 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 26 months is below that.

Counting every sponsor, half of 1,050 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2021
First posted
Jun 30, 2021
StartActual
Aug 5, 2021
Primary completionActual
Oct 28, 2023
CompletionEst.
Jan 28, 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04945746
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Jun 30, 2021
Start date
Aug 5, 2021
Primary completion
Oct 28, 2023
Completion
Jan 28, 2025 (estimated)
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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