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Smart software aims to improve repeat heart ablation for AFib

NCT ID NCT05477147

Disease control Sponsor: Volta Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new approach for repeat catheter ablation in people with atrial fibrillation (AF) whose symptoms returned after a previous ablation. Doctors used a special software algorithm (VX1) to guide the procedure. The study included 96 adults and measured how many stayed free from AF episodes for one year after the repeat ablation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
catheter ablation guided by VX1 algorithm
What this could lead to
If successful, this approach could improve the success rate of repeat ablation procedures for atrial fibrillation, reducing the need for further treatments.
What could go wrong
This was a small, non-randomized study with no control group, so results may not be definitive. The procedure carries standard risks of catheter ablation, such as bleeding or heart rhythm issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

96 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 21 years of age or older indicated for redo AF ablation 2. Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF 3. Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure 4. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \> 4 weeks prior to ablation 5. Patients must be able and willing to provide written informed consent to participate in the clinical trial Exclusion Criteria: 1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.) 2. First AF ablation procedure indication was persistent AF lasting longer than 24 months 3. Long-standing persistent AF recurrence prior to study redo procedure 4. Previous AF ablation using VX1 software 5. Severe obesity (BMI \> 50) 6. Very dilated Left Atrium (LA) (e.g. LA diameter \> 55 mm and/or LA surface \> 40 cm2 determined by 2D echocardiography) 7. Patients with AF secondary to an obvious reversible cause 8. Inadequate anticoagulation as defined in the inclusion criteria 9. LA thrombus on Transesophageal Echocardiography (TEE)\* or CT Scan prior to procedure 10. Contraindications to anticoagulation (heparin, warfarin or NOAC) 11. Patients who are or may potentially be pregnant 12. Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI) 13. Myocardial infarction within the past 2 months (60 days) 14. Previous AV valve surgery 15. Patient diagnosed with hypertrophic cardiomyopathy 16. History of blood clotting or bleeding abnormalities 17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days) 18. Rheumatic Heart Disease 19. Cardiac Sarcoidosis 20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF \< 25%) 21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 22. Unstable angina within the past month 23. Acute illness or active systemic infection or sepsis 24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 25. Diagnosed atrial myxoma 26. 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) 27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment 28. Enrollment in an investigational study evaluating another device, biologic, or drug 29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter 30. Life expectancy or other disease processes likely to limit survival to less than 12 months 31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Ascension St. Vincent's Hospital

    Jacksonville, Florida, 32204, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02241, United States

  • Clinique Pasteur

    Toulouse, 31076, France

  • Deutsches Herzzentrum München

    München, 80636, Germany

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Hôpital Privé Jacques Cartier

    Massy, 91300, France

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22042, United States

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas, 66211, United States

  • Loyola University

    Maywood, Illinois, 60152, United States

  • Northshore University Health System

    Evanston, Illinois, 60201, United States

  • Northwell Health System

    New York, New York, 11030, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • OLV Aalst

    Aalst, 9300, Belgium

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Washington University

    St Louis, Missouri, 63130, United States

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