Trials / Completed
CompletedNCT05089877
FREEZE-AFIB Post-Market Study
Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
Detailed description
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surgical Ablation | The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. |
Timeline
- Start date
- 2022-04-29
- Primary completion
- 2023-03-31
- Completion
- 2023-12-31
- First posted
- 2021-10-22
- Last updated
- 2025-01-13
- Results posted
- 2025-01-13
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05089877. Inclusion in this directory is not an endorsement.