VOLT-AF IDE Clinical Study

Completed · Not applicable

Conditions studied: Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06223789

Run by

Abbott Medical Devices

People needed

392

Starts

2024-04-03

Expected to finish

2025-10-03

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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
• 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

Where it is running

• Affinity Cardiovascular Specialists, LLC — Birmingham, Alabama, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center - Van Ness Campus — San Francisco, California, United States
• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• AdventHealth Orlando — Orlando, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
• Johns Hopkins University Hospital — Baltimore, Maryland, United States
• Southcoast Hospitals Group - Charlton Memorial Hospital — Fall River, Massachusetts, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Northwell Health - Lenox Hill Hospital — New York, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Hightower Clinical — Oklahoma City, Oklahoma, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Trident Medical Center — Charleston, South Carolina, United States
• Texas Cardiac Arrhythmia — Austin, Texas, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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