VOLT-AF IDE Clinical 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Atrial Arrhythmia
• Intervention / Treatment: Device: Pulsed Field Ablation

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).

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Chermside, Australia, 4032
    • The Prince Charles Hospital
  • Clayton, Australia, 3168
    • Monash Health
  • Parkville, Australia, 3050
    • Royal Melbourne Hospital
• Austria
  • Linz, Austria, 4020
    • A.o. Krankenhaus der Elisabethinen Linz
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint Jan
  • Brussels, Belgium, 1090
    • Uz Brussel
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • McGill University Health Centre General Hospital
• Czechia
  • Prague, Czechia, 15030
    • Nemocnice Na Homolce
• France
  • Paris, France, 75651
    • Hôpital Pitié Salpetrière
• Italy
  • Ancona, Italy, 60126
    • Az. Osp. Universitaria Osp. Riuniti Umberto I-Lancisi-Salesi
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Spain
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Affinity Cardiovascular Specialists, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Northside Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Southcoast Hospitals Group - Charlton Memorial Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • New York
    • New York, New York, United States, 10021
      • Northwell Health - Lenox Hill Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
   • 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.

2. 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
3. At least 18 years of age
4. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
5. 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.

Exclusion Criteria:

1. Previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
2. 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
3. Patient known to require ablation beyond PVI at the time of consent.
4. Known presence of cardiac thrombus
5. Left atrial diameter ≥ 5.5 cm (anteroposterior diameter) within 180 days of index procedure.
6. Left ventricular ejection fraction < 35% as assessed with echocardiography within 180 days of index procedure
7. New York Heart Association (NYHA) class III or IV heart failure
8. Body mass index > 40 kg/m2
9. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
10. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure,
11. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
12. Unstable angina
13. Stroke or TIA (transient ischemic attack) within the last 90 days
14. Heart disease in which corrective surgery is anticipated within 180 days after procedure
15. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
16. Contraindication to long term anti-thromboembolic therapy
17. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
19. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
20. Presence of any condition that precludes appropriate vascular access
21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
22. Previous tricuspid or mitral valve replacement or repair
23. Patients with prosthetic valves
24. Patients with a myxoma
25. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
26. Stent, constriction, or stenosis in a pulmonary vein
27. Rheumatic heart disease
28. Hypertrophic cardiomyopathy
29. Diagnosed with amyloidosis or atrial amyloidosis
30. Active systemic infection
31. Renal failure requiring dialysis
32. 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
33. 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.
34. Presence of an implanted LAA closure device or plans to have an LAA closure device implanted during the follow-up period
35. 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
36. Unlikely to survive the protocol follow up period of 12 months
37. 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.
38. Individuals without legal authority
39. Individuals unable to read or write

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volt PFA Catheter Sensor Enabled (SE)	Device: Pulsed Field Ablation; Pulsed field ablation using the Volt PFA System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7-days
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).	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12-months
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)	12-months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Sarah Kammer, Abbott

Publications and helpful links

General 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: One-Year Outcomes of the VOLT-AF IDE Study. JACC Clin Electrophysiol. 2026 Feb 5:S2405-500X(26)00010-1. doi: 10.1016/j.jacep.2026.01.006. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): October 3, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; PFA; Atrial Arrhythmia; Pulsed Field Ablation; Paroxysmal AF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: ABT-CIP-10514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No