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Atrial ArrhythmiaNCT06223789

VOLT-AF IDE Clinical Study

A study testing Pulsed Field Ablation in people with Atrial Arrhythmia and Atrial Fibrillation, run by Abbott Medical Devices at 40 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pulsed Field Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
40 sitesin 11 countries
Study dates
3 Apr 2024to 3 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
  • Paroxysmal:
  • Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
  • One electrocardiographically documented PAF episode within 12 months prior to enrollment.
  • Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
  • Physician's note, AND either
Show all 16Show fewer
  • 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR
  • Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
  • That are taken at least 7 days apart but less than 12 months apart
  • If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
  • The most recent electrocardiogram must be within 180 days of enrollment.
  • NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
  • Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
  • At least 18 years of age
  • Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
  • Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Who cannot join

  • Previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
  • Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
  • Patient known to require ablation beyond PVI at the time of consent.
  • Known presence of cardiac thrombus
  • Left atrial diameter ≥ 5.5 cm (anteroposterior diameter) within 180 days of index procedure.
  • Left ventricular ejection fraction < 35% as assessed with echocardiography within 180 days of index procedure
Show all 39Show fewer
  • New York Heart Association (NYHA) class III or IV heart failure
  • Body mass index > 40 kg/m2
  • Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
  • Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure,
  • Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
  • Unstable angina
  • Stroke or TIA (transient ischemic attack) within the last 90 days
  • Heart disease in which corrective surgery is anticipated within 180 days after procedure
  • History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
  • Contraindication to long term anti-thromboembolic therapy
  • Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  • Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
  • Presence of any condition that precludes appropriate vascular access
  • Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
  • Previous tricuspid or mitral valve replacement or repair
  • Patients with prosthetic valves
  • Patients with a myxoma
  • Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
  • Stent, constriction, or stenosis in a pulmonary vein
  • Rheumatic heart disease
  • Hypertrophic cardiomyopathy
  • Diagnosed with amyloidosis or atrial amyloidosis
  • Active systemic infection
  • Renal failure requiring dialysis
  • Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.
  • Presence of an implanted LAA closure device or plans to have an LAA closure device implanted during the follow-up period
  • Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor
  • Unlikely to survive the protocol follow up period of 12 months
  • Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Individuals without legal authority
  • Individuals unable to read or write

Trial locations and contacts

40 sites in 11 countries.

40 sites in 11 countries

United States26 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21287

  • Affinity Cardiovascular Specialists, LLC

    Birmingham, Alabama, 35243

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Southcoast Hospitals Group - Charlton Memorial Hospital

    Fall River, Massachusetts, 02720

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Northwell Health - Lenox Hill Hospital

    New York, New York, 10021

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211

  • California Pacific Medical Center - Van Ness Campus

    San Francisco, California, 94109

  • AdventHealth Tampa

    Tampa, Florida, 33613

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • The Prince Charles Hospital

    Chermside, 4032

  • Monash Health

    Clayton, 3168

  • Royal Melbourne Hospital

    Parkville, 3050

Other trials in Australia

Belgium2 sites

  • AZ Sint Jan

    Bruges, 8000

  • UZ Brussel

    Brussels, 1090

Other trials in Belgium

Austria1 site

  • A.o. Krankenhaus der Elisabethinen Linz

    Linz, 4020

Other trials in Austria

Canada1 site

  • McGill University Health Centre General Hospital

    Montreal, Quebec, H4A3J1

Other trials in Canada

Czechia1 site

  • Motol and Homolka University Hospital

    Prague, 15030

Other trials in Czechia

France1 site

  • Hopital Pitie Salpetriere

    Paris, 75651

Other trials in France

Italy1 site

  • Az. Osp. Universitaria Osp. Riuniti Umberto I-Lancisi-Salesi

    Ancona, 60126

Other trials in Italy

Netherlands1 site

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Spain1 site

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom1 site

  • St. Bartholomew's Hospital

    London, EC1A 7BE

Other trials in United Kingdom

About this study

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Read the detailed description

This is a pre-market, prospective, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF).

Being tested
Pulsed Field Ablation
Keywords
Atrial Arrhythmia, Paroxysmal AF, PFA, Persistent Atrial Fibrillation, Pulsed Field Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsed Field AblationDevice

    Pulsed field ablation using the Volt PFA System

Study groups in NCT06223789
Study groupRoleWhat they receive
Volt PFA Catheter Sensor Enabled (SE)ExperimentalNot described
Receives: Device: Pulsed Field Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.

    Serious adverse events are defined as:

    • Atrio-esophageal fistula
    • Cardiac tamponade/perforation
    • Death
    • Heart block
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve injury resulting in permanent diaphragmatic paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis
    • Stroke/cerebrovascular accident
    • Thromboembolism
    • Transient ischemic attack
    • Vagal nerve injury/gastroparesis
    • Major vascular access complications / major bleeding events
    • Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)

    Measured: 7-days

  2. Longterm Effectiveness

    Rate of freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up (after a 90-day blanking period following the index ablation procedure).

    Measured: 12-months

Secondary outcomes (2)

  1. Symptomatic Effectiveness

    Rate of freedom from documented symptomatic AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up (after a 90-day blanking period following the index ablation procedure).

    Measured: 12-months

  2. AAD-Free Effectiveness

    Rate of freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up off all Class I and III AADs (after a 90-day blanking period following the index ablation procedure)

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start3 Apr 2024
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223789
Sponsor's protocol ID
ABT-CIP-10514
Status last verified
May 2026
First submitted
16 Jan 2024
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Verma A, Lo M, Woods CE, Hussein AA, Gambhir A, Sundaram S, Sanders P, DeLurgio D, Mountantonakis SE, Neuzil P, Osca J, Trivedi A, Loh P, Calkins H, Strouse D, Chierchia GB, Atwater B, Kalman J, Puererfellner H, Russo AD, Davoudi R, Schilling R, Lin W, Miller A, Jesser E, Lakkireddy D. Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation: 1-Year Outcomes of the VOLT-AF IDE Study. JACC Clin Electrophysiol. 2026 Jun;12(6):1287-1299. doi: 10.1016/j.jacep.2026.01.006. Epub 2026 Feb 5.

    PubMed 41649432

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Field Ablation in people with Atrial Arrhythmia and Atrial Fibrillation, run by Abbott Medical Devices at 40 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Australia, Belgium, Austria, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System. (time frame: 7-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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