Trials / Not Yet Recruiting
Not Yet RecruitingNCT07428564
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation System | Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
- First posted
- 2026-02-23
- Last updated
- 2026-03-13
Locations
10 sites across 7 countries: Belgium, Denmark, France, Germany, Italy, Lithuania, Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07428564. Inclusion in this directory is not an endorsement.