Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

Study Overview
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Brief Summary
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Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.

Official Title
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Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 21 years of age or older indicated for redo AF ablation Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure 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 Exclusion Criteria: Previous ablation procedure-related complication (e.g. fistula, perforation, etc.) First AF ablation procedure indication was persistent AF lasting longer than 24 months Long-standing persistent AF recurrence prior to study redo procedure Previous AF ablation using VX1 software Severe obesity (BMI > 50) Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography) Patients with AF secondary to an obvious reversible cause Inadequate anticoagulation as defined in the inclusion criteria LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure Contraindications to anticoagulation (heparin, warfarin or NOAC) Patients who are or may potentially be pregnant Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI) Myocardial infarction within the past 2 months (60 days) Previous AV valve surgery Patient diagnosed with hypertrophic cardiomyopathy History of blood clotting or bleeding abnormalities Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days) Rheumatic Heart Disease Cardiac Sarcoidosis Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%) 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 AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Diagnosed atrial myxoma Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea) Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment 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 months Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Patients undergoing catheter ablation that qualify after initial screening. | Device: Catheter Ablation<br>* Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from AF | Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, AF, Artificial intelligence, Catheter Ablation, Ablation