Trials / Completed
CompletedNCT06223789
VOLT-AF IDE Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 392 (actual)
- 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
This is a pre-market, prospective, 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation | Pulsed field ablation using the Volt PFA System |
Timeline
- Start date
- 2024-04-03
- Primary completion
- 2025-10-03
- Completion
- 2025-10-03
- First posted
- 2024-01-25
- Last updated
- 2026-03-13
Locations
40 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06223789. Inclusion in this directory is not an endorsement.