VOLT CE Mark Study

NCT06106594 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10456
• Study Type: interventional
• Target: 300
• Locations: 6 countries
• Sites: 10

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

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 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

• Acute procedural effectiveness summarized as the rate of pulmonary veins treated with the Volt PFA system that are isolated at the end of the index ablation procedure.

  Acute procedural failure for each pulmonary vein is defined as any of the following: 1. Inability to isolate a pulmonary vein at the end of the index ablation procedure. Isolation will be assessed via confirmation of electrical isolation in each ablated pulmonary vein after a minimum waiting period of 20 minutes via entrance block at a minimum. Touch-up ablation to achieve isolation will be allowed for any pulmonary vein reconnection detected during the index procedure with the investigational catheter (to the maximum delivery allowed per vein) and will not be considered a failure. 2. Any use of a non-study ablation device for pulmonary vein isolation.

  During procedure

• Long-term 6-month effectiveness summarized as the rate of freedom from documented AF/AFL/AT episodes of >30 seconds duration after the index ablation procedure through 6 months of follow-up.

  The situations in which subjects will be considered long-term effectiveness endpoint failures: * Acute procedural failure * Any use of a non-study ablation device for pulmonary vein isolation or to deliver ablation lesions in the left atrium during the index procedure or during the first repeat procedure. * If documented AF/AFL/AT recurrence occurs at any time after the blanking period * If subject requires a repeat procedure for the treatment of AF, non-CTI-dependent AFL, or AT after the blanking period or a second repeat AF ablation procedure at any time after the index ablation procedure. * Any use of a new class I or III AAD for AF after the blanking period. * Any use of a class I or III AAD for AF at a dose higher than the historical maximum dose for the subject after the blanking period. * If the subject requires a cardioversion for the treatment of AF/AFL/AT after the blanking period * Surgical treatment of AF/AFL/AT post index procedure.

  6 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 episodes 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 (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
• Participant known to require ablation beyond PVI at the time of consent (Main study only)
• Known presence of cardiac thrombus
• Left atrial diameter ≥ 5.5 cm (anteroposterior diameter)
• 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 28 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 sate

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

The Prince Hospital

Chermside, Queensl, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, Saustrl, 5000, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Royal Melbourne Hospital - City Campus

Parkville, Victoria, 3050, Australia

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, 4020, Austria

Location

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

AZ Sint Jan

Bruges, Wflndrs, 8000, Belgium

Location

Nemocnice Na Homolce

Prague, Cbohmia, 15030, Czechia

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schlesw, 23562, Germany

Location

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (2)

• Tilz RR, Chierchia GB, Gunawardene M, Sanders P, Haqqani H, Kalman J, Healy S, Purerfellner H, Neuzil P, Asensi JO, Loh P, Reddy VY, Knecht S, Jesser E, Dirckx N, Miller A, Walker D, Lakkireddy D. Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results. Europace. 2025 Mar 28;27(4):euaf072. doi: 10.1093/europace/euaf072.

  PMID: 40163671 RESULT

• Sanders P, Healy S, Emami M, Kotschet E, Miller A, Kalman JM. Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study. Europace. 2024 May 2;26(5):euae118. doi: 10.1093/europace/euae118.

  PMID: 38701222 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristin Ruffner

  Abbott

  STUDY DIRECTOR

Study Design

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

Model Details: Main study enrollment will include up to 150 subjects, enrollment extension cohort will include up to 100 subjects.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 30, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); BE (2); NL (1); CZ (1); ES (1); DE (1)