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VOLT CE Mark Study | Clinical Trials | Clareo Health

RECRUITINGNA

VOLT CE Mark Study

NCT06106594•Abbott Medical Devices

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.

Detailed Description

The main study is a pre-market, prospective, single-arm, 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). The main study design includes a feasibility sub-study in which additional imaging assessments will be collected in a small cohort of subjects to confirm acute safety of the Volt PFA System in humans. The enrollment extension will include up to an additional 150 subjects enrolled with market-released or investigational devices, depending on enrollment geography.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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
•* 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
+6 more criteria

Exclusion Criteria

•1. Previously diagnosed long-standing persistent atrial fibrillation (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. Participant known to require ablation beyond PVI at the time of consent (Main study only)
•4. Known presence of cardiac thrombus
•5. Left atrial diameter ≥ 5.5 cm (anteroposterior diameter)
•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 28 days of procedure,
+29 more criteria

Locations (16)

The Prince Hospital

Chermside, Queensl, Australia

Royal Adelaide Hospital

Adelaide, Saustrl, Australia

Monash Health

Clayton, Victoria, Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, Austria

UZ Brussel

Brussels, Brussels Capital, Belgium

AZ Sint Jan

Bruges, Wflndrs, Belgium

Nemocnice Na Homolce

Prague, Cbohmia, Czechia

Medizinische Einrichtungen der Universität zu Köln

Cologne, N. RHIN, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schlesw, Germany

Key Dates

Start Date

October 24, 2023

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

October 20, 2025

Enrollment

300

ESTIMATED participants

Conditions

Atrial ArrhythmiaAtrial FibrillationParoxysmal Atrial FibrillationPersistent Atrial Fibrillation

Interventions

Pulsed Field Ablation

DEVICE

Contacts

Jessica Arrett

CONTACT

(+1) 612-380-8445 jessica.arrett@abbott.com

Amber Miller

CONTACT

(+1) 651-756-2885 amber.miller@abbott.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VOLT CE Mark Study

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Medtronic Terminate AF Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia