VOLT-AF IDE Clinical Study

NCT06223789 | Completed DMC FDA Device

• 1 other identifier: ABT-CIP-10514
• Study Type: interventional
• Target: 392
• Locations: 10 countries
• Sites: 39

Brief 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 collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Conditions

Atrial Arrhythmia; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

Atrial Arrhythmia; Paroxysmal AF; PFA; Persistent Atrial Fibrillation; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Symptomatic Effectiveness

  12-months

• AAD-Free Effectiveness

  12-months

Study Arms (1)

Volt PFA Catheter Sensor Enabled (SE)

EXPERIMENTAL

Device: Pulsed Field Ablation

Interventions

Pulsed Field Ablation DEVICE

Pulsed field ablation using the Volt PFA System

Volt PFA Catheter Sensor Enabled (SE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (40)

Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, 35243, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Southcoast Hospitals Group - Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10021, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

The Prince Charles Hospital

Chermside, 4032, Australia

Location

Monash Health

Clayton, 3168, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

A.o. Krankenhaus der Elisabethinen Linz

Linz, 4020, Austria

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

McGill University Health Centre General Hospital

Montreal, Quebec, H4A3J1, Canada

Location

Nemocnice Na Homolce

Prague, 15030, Czechia

Location

Hopital Pitie Salpetriere

Paris, 75651, France

Location

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

Ancona, 60126, Italy

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

St. Bartholomew&amp;#39;s Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41649432 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Kammer

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: April 3, 2024
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); BE (2); US (26); AU (4); CZ (1); IT (1); NL (1); ES (1); GB (1); FR (1)