Trials / Active Not Recruiting
Active Not RecruitingNCT03732794
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.
Detailed description
The AtriCure CryoICE Ablation System is being studied to ablate cardiac tissue during surgery for the treatment of Persistent and Long-standing Persistent atrial fibrillation in open concomitant cardiac surgery. The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AtriCure CryoICE & AtriClip LAA Exclusion | AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device. |
Timeline
- Start date
- 2019-01-30
- Primary completion
- 2024-06-27
- Completion
- 2026-06-01
- First posted
- 2018-11-07
- Last updated
- 2024-10-15
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03732794. Inclusion in this directory is not an endorsement.