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OpenTrials
Active, Not Recruiting

NCT Number: NCT04945746

Dispersion Stability

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Joseph Marseille

Marseille, 13008, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

AF ablation

Procedure

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").

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

Study Evaluating the Prioritization of Ablation Zones According to the Stability of the Dispersion

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jun 30, 2021
Registry last updated
Sep 19, 2024

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.

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