Trials / Completed
CompletedNCT02393885
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
Detailed description
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2022-03-28
- Completion
- 2024-04-17
- First posted
- 2015-03-20
- Last updated
- 2024-12-19
- Results posted
- 2024-12-19
Locations
17 sites across 3 countries: United States, Belgium, Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02393885. Inclusion in this directory is not an endorsement.