Dispersion Stability

NCT04945746 | Active Not Recruiting

• 1 other identifier: HSJ_Dispersion Stability_2021
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

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

  at the end of the procedure

Study Arms (1)

Software VX1 + Stability

EXPERIMENTAL

Utilization of the software VX1 + Stability

Procedure: AF ablation

Interventions

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").

Software VX1 + Stability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hôpital Saint Joseph Marseille

Marseille, 13008, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: August 5, 2021
• Primary Completion: October 28, 2023
• Study Completion: January 28, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)