Trials / Completed
CompletedNCT04468334
aMAZE Trial Continued Access Protocol
Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites.
Detailed description
For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility criteria and follow up visit assessments remain unchanged from the current aMAZE Trial investigation (NCT02517397).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LARIAT + PVI | LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures |
Timeline
- Start date
- 2020-03-09
- Primary completion
- 2023-04-24
- Completion
- 2023-04-24
- First posted
- 2020-07-13
- Last updated
- 2024-03-12
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04468334. Inclusion in this directory is not an endorsement.