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VOLT CE Mark Study

StatusActive, Not Recruiting
PhaseNot applicable
Started2023-10-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 6, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-05-04
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sites16→11
2025-10-15
Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Contacts/Locations, References v5
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2024-09-30→2026-06
Completion date2026-09→2026-12
Enrollment target250→300
Study sites11→16
Study descriptionrevised
[...] . The enrollment extension will include up to an additional 100150 subjects enrolled with market-released or investigational devices, depending on enrollment geography.
Publicationsdetails revised at 2 of 2 entries
2025-04-05
Withheld→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v4
Trial statusWithheld→Active, Not Recruiting
Primary completion datenot stated→2024-09-30
Completion datenot stated→2026-09
Start datenot stated→2023-10-24
Lead sponsor[Redacted]→Abbott Medical Devices
Study title-47 characters
[TrialVOLT ofCE deviceMark that is not approved or cleared by the U.S. FDA]Study
2024-03-28
3 amendments v1-v3
3 re-verifications since 2023-11-08, no change to tracked fields
2023-10-24
Original filing
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.
Trial Details
NCT Number NCT06106594
Lead Sponsor Abbott Medical Devices
Conditions Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Enrollment 300 participants
Start Date 2023-10-24
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-06