Dispersion Stability

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.

Study Overview

• Status: Suspended
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: AF ablation

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13008
    • Hôpital Saint Joseph Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
3. Patients must be able and willing to provide written informed consent 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:

1. Paroxysmal and short-standing persistent AF < 3 months
2. Severe obesity (BMI > 45)
3. LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
4. Contraindications 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 TIA) 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 investigational 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. 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
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Software VX1 + Stability; Utilization of the software VX1 + Stability	Procedure: AF 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").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF termination rate after ablation of the most stable regions (levels 3 and 2)	sinus rhythm at the end of the procedure	at the end of the procedure

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): October 28, 2023
• Study Completion (Anticipated): January 28, 2024

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HSJ_Dispersion Stability_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No