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Dispersion Stability

Primary Purpose

Atrial Fibrillation

Status

Suspended

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

AF ablation

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Saint Joseph Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Software VX1 + Stability

Arm Description

Utilization of the software VX1 + Stability

Outcomes

Primary Outcome Measures

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

sinus rhythm at the end of the procedure

Secondary Outcome Measures

Full Information

NCT ID

NCT04945746

First Posted

June 22, 2021

Last Updated

January 13, 2022

Sponsor

Hospital St. Joseph, Marseille, France

1. Study Identification

Unique Protocol Identification Number

NCT04945746

Brief Title

Dispersion Stability

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Suspended

Why Stopped

technical problem with VX1 software

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

October 28, 2023 (Anticipated)

Study Completion Date

January 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Software VX1 + Stability

Arm Type

Experimental

Arm Description

Utilization of the software VX1 + Stability

Intervention Type

Procedure

Intervention Name(s)

AF ablation

Intervention Description

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 Outcome Measure Information:

Title

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

Description

sinus rhythm at the end of the procedure

Time Frame

at the end of the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Hôpital Saint Joseph Marseille

City

Marseille

ZIP/Postal Code

13008

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Dispersion Stability

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