Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05477147

Run by

Volta Medical

People needed

96

Starts

2023-03-17

Expected to finish

2025-09-30

Last updated by the study team

2025-12-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Ascension St. Vincent's Hospital — Jacksonville, Florida, United States
• Northshore University Health System — Evanston, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Loyola University — Maywood, Illinois, United States
• Kansas City Cardiac Arrhythmia Research LLC — Overland Park, Kansas, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Northwell Health System — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• Inova Fairfax Hospital — Fairfax, Virginia, United States
• OLV Aalst — Aalst, Belgium
• Hôpital Privé Jacques Cartier — Massy, France
• Clinique Pasteur — Toulouse, France
• Deutsches Herzzentrum München — München, Germany

Full record on ClinicalTrials.gov

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