BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

NCT07181590 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10608
• Study Type: interventional
• Target: 300
• Locations: 12 countries
• Sites: 22

Brief Summary

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Conditions

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

Keywords

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Pulsed Field Ablation; Persistent Field Ablation

Outcome Measures

Primary Outcomes (3)

• Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF

  Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis3 * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary Edema * Pulmonary vein stenosis1 * Stroke * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications4 / major bleeding events5 * Device 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

• Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.

  Other situations in which subjects will be considered effectiveness endpoint failures include: * Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period. * A second repeat procedure for ablation of AF recurrence within the 90-day blanking period * Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period * Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period * Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.

  During procedure

• Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins

  A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) : * A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or * Exit block pacing maneuvers ; or * Isoproterenol or adenosine challenge

  During procedure

Study Arms (1)

Volt PFA Catheter Sensor Enabled (SE)

OTHER

Patients diagnosed with drug refractory, symptomatic, recurrent, paroxysmal and persistent atrial fibrillation that will undergo a de novo ablation procedure with the Volt PFA Catheter.

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 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 360 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 de novo ablation procedure with the Volt PFA Catheter 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:

• 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
• Known presence of cardiac thrombus
• Known Left ventricular ejection fraction \< 35% as assessed with echocardiography within 360 days of index procedure
• New York Heart Association (NYHA) class III or IV heart failure
• 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
• Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (22)

Ordensklinikum Linz Elisabethinen

Linz, 4020, Austria

RECRUITING

AZ Sint Jan

Bruges, 8000, Belgium

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Hôpital Pitié Salpetrière

Paris, 75013, France

RECRUITING

Hopital Haut Leveque

Pessac, 33600, France

RECRUITING

Clinique Pasteur Toulouse

Toulouse, 31076, France

RECRUITING

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, 32545, Germany

RECRUITING

Medizinische Einrichtungen der Universität zu Köln

Cologne, 50937, Germany

RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

RECRUITING

TUM Klinikum - Deutsches Herzzentrum München

München, 80636, Germany

RECRUITING

Mater Private Hospital

Dublin, DUBLIN 7, Ireland

RECRUITING

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

Ancona, 60126, Italy

RECRUITING

Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

RECRUITING

National Institute of Cardiology Warsaw

Warsaw, 04-628, Poland

RECRUITING

ULS de Lisboa Ocidental

Lisbon, 2799-523, Portugal

RECRUITING

Hospital Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

RECRUITING

Karolinska University Hospital Huddinge

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah C Kammer

  Abbott Medical Devices

  STUDY DIRECTOR

Central Study Contacts

Karolilen Timmermans

CONTACT

+3222006511; karolien.timmermans@abbott.com

Christine Sasaridis

CONTACT

christine.sasaridis@abbott.com

Study Design

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

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); IT (2); PT (1); NL (2); BE (2); DK (1); DE (4); IE (1); AU (1); ES (3); SE (1); PL (1)