NCT06106594

VOLT CE Mark Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Arrhythmia
• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulsed Field Ablation	Pulsed field ablation using the Volt PFA System

Timeline

• Start date: 2023-10-24
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-10-30
• Last updated: 2025-10-20

Locations

16 sites across 10 countries: Australia, Austria, Belgium, Czechia, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study