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VOLT CE Mark Study

NCT06106594 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

Pulsed Field Ablation

Pulsed field ablation using the Volt PFA System

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kristin Ruffner · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106594 on ClinicalTrials.gov