Trials / Recruiting
RecruitingNCT06772493
ViewFlex X ICE First-in-Human Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ViewFlex X ICE System | Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System |
Timeline
- Start date
- 2024-12-16
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-01-13
- Last updated
- 2026-03-19
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06772493. Inclusion in this directory is not an endorsement.