Trials / Recruiting
RecruitingNCT07181590
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
- 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 study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation | Pulsed Field Ablation using the Volt PFA System |
Timeline
- Start date
- 2025-12-11
- Primary completion
- 2027-08-01
- Completion
- 2027-08-01
- First posted
- 2025-09-18
- Last updated
- 2026-04-08
Locations
22 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07181590. Inclusion in this directory is not an endorsement.