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Personalized heart ablation may beat standard procedure for AFib

NCT ID NCT04702451

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a tailored ablation approach, which targets specific abnormal areas in the heart, works better than the standard anatomical ablation for people with persistent atrial fibrillation (AFib). 377 adults with AFib that didn't respond to medication were included. The tailored method uses a special mapping system to find and burn problem spots, while the standard method only isolates the pulmonary veins. The main goal was to see who stayed free of AFib for 12 months after one procedure.

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 procedure
What this could lead to
If successful, this tailored approach could improve freedom from atrial fibrillation after a single procedure, reducing the need for repeat treatments.
What could go wrong
This is a completed study, but results may not apply to all patients. The tailored strategy is more complex and may carry higher risks like heart tissue damage or bleeding.

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

377 people

The number who actually took part.

Started

Feb 2021

Finished

Dec 2023

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

18 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: * Patients 18 years of age or older candidates for a first AF ablation * Symptomatic AF, refractory to at least one antiarrhythmic medication * Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and \< 1 year in the United States) 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 * At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months Exclusion Criteria: * Paroxysmal and short-standing AF \< 3 months * Long-standing persistent AF \> 5 years (≥ 1 year in the United States) * ≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration * Severe obesity (BMI \> 40) * Very dilated Left Atrium (LA)(e.g. LA diameter \> 60 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 * Previous surgical or catheter ablation for AF * Any cardiac surgery within the past 2 months (60 days) (includes PCI) * Myocardial infarction within the past 2 months (60 days) * Previous atrioventricular valve surgery * History of blood clotting or bleeding abnormalities * Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days) * Rheumatic Heart Disease * 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)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent 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

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Cardiologique du Nord

    Saint-Denis, 93200, France

  • Clinique Pasteur

    Toulouse, 31076, France

  • Clinique Rhéna

    Strasbourg, 67000, France

  • Clinique Saint George

    Nice, 06105, France

  • Deutsches Herzzentrum München

    München, 80636, Germany

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Hôpital Louis Pradel - Hospices Civils de Lyon

    Lyon, 69677, France

  • Hôpital Privé Jacques Cartier

    Massy, 91300, France

  • Hôpital Privé du Confluent

    Nantes, 44200, France

  • Hôpital Saint Philibert

    Lomme, 59462, France

  • Hôpital Saint-Joseph

    Marseille, 13008, France

  • Inova Fairfax

    Falls Church, Virginia, 22042, United States

  • Isala Hartcentrum Zwolle

    Zwolle, 8025, Netherlands

  • Klinikum Coburg

    Coburg, 96450, Germany

  • New York Presbyterian Queens Hospital

    Queens, New York, 11355, United States

  • Northwell Health

    New York, New York, 10075, United States

  • OLV Aalst

    Aalst, 9300, Belgium

  • OLVG Amsterdam

    Amsterdam, 1091, Netherlands

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Pôle Santé République

    Clermont-Ferrand, 63000, France

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133, Germany

  • UZ Leuven

    Leuven, 3000, Belgium

  • Washington University

    St Louis, Missouri, 63130, United States

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