Atrial FibrillationNCT04945746
Dispersion Stability
A study testing AF ablation in people with Atrial Fibrillation, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial 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. 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?
- AF ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 28 Jan 2025
- 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
- Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter):
- AF duration of ≥ 3 months and ≤ 5 years or
- 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
- Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
- Maximum of 50% of patients (13 patients) in persistent AF < 12 months (>30% of long-standing persistent AF ≥ 12 months)
- Being affiliated to a social security scheme or beneficiary of such a scheme
Who cannot join
- Paroxysmal and short-standing persistent AF < 3 months
- Severe obesity (BMI > 45)
- LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
- Contraindications to anticoagulation (heparin, warfarin or NOAC)
- Patients who are or may potentially be pregnant
- Any cardiac surgery within the past 2 months (60 days) (includes PCI)
Show all 18Show fewer
- Myocardial infarction within the past 2 months (60 days)
- History of blood clotting or bleeding abnormalities
- Documented thromboembolic event (including TIA) within the past 12 months (365 days)
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- Unstable angina within the past month
- Acute illness or active systemic infection or sepsis (including COVID 19)
- Enrollment in an investigational study evaluating another device, biologic, or drug
- Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- Life expectancy 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
- Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
- Patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
- Person subject to a safeguard measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Prioritization of Ablation Zones According to the Stability of the Dispersion
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.
- Conditions
- Atrial Fibrillation
- Being tested
- AF 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.
AF ablationProcedure or surgery
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").
| Study group | Role | What they receive |
|---|---|---|
| Software VX1 + Stability | Experimental | Utilization of the software VX1 + Stability Receives: Procedure: AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF termination rate after ablation of the most stable regions (levels 3 and 2)
sinus rhythm at the end of the procedure
Measured: at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start5 Aug 2021
- Primary completion28 Oct 2023
- Study completion28 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945746
- Sponsor's protocol ID
- HSJ_Dispersion Stability_2021
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Prioritization of Ablation Zones According to the Stability of the Dispersion
- ClinicalTrials.gov ID
- NCT04945746
- Acronym / sponsor ID
- HSJ_Dispersion Stability_2021
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Jan 2025 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Software VX1 + Stability | Experimental | Procedure: AF ablationUtilization of the software VX1 + Stability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter):
- Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
- Maximum of 50% of patients (13 patients) in persistent AF < 12 months (>30% of long-standing persistent AF ≥ 12 months)
- Being affiliated to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (18 listed)
- Paroxysmal and short-standing persistent AF < 3 months
- Severe obesity (BMI > 45)
- LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
- Contraindications to anticoagulation (heparin, warfarin or NOAC)
- Patients who are or may potentially be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF ablationAF 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"). | Procedure or surgery | Software VX1 + Stability |
Primary outcome
AF termination rate after ablation of the most stable regions (levels 3 and 2)
Time frame: at the end of the procedure
sinus rhythm at the end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation in people with Atrial Fibrillation, run by Hospital St. Joseph, Marseille, France at 1 site 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
AF termination rate after ablation of the most stable regions (levels 3 and 2) (time frame: at the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.